BD BACTEC™ Blood Culture
Vial Supply

Hotline: 1.888.834.4332

We recognize the urgent need to restore production of BD BACTEC™ blood culture vials and addressing immediate customer demand is our top priority.

Updated November 5, 2024
What’s new

A message from BD leadership

  • We continue to see steady improvements and consistency from our supplier’s output of plastic vials and are making progress improving BD BACTEC™ blood culture media availability.
  • We continue to realize allocation above 100% of historic demand, which contributes to increasing inventory in distribution warehouses around the United States.
  • We are collaborating with our distribution partners to explore all options to drive increased inventory levels in warehouses across the United States.
  • We are encouraging U.S. customers using BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials to convert temporarily to glass vials, which will accelerate the resupply significantly.
  • We have provided guidance on converting to glass in the Resources section and the FAQs.

BD BACTEC™ update

This website provides important information about continuing actions to restore supply of BD BACTEC™ blood culture vials in the U.S. market and progress to date.

Since July 1 production and allocation to customers has substantially increased at a progressive pace. As of October, production levels have increased to the point that allocations continue to meet and, in multiple weeks, exceed 100% of historical customer demand. We continue to focus on replenishing inventories at our distributor partners to enable our customers to build stock within their facilities.

The steady recovery in our supply of BD BACTEC™ blood culture vials is due to actions we launched in early summer internally within the BD supply chain system and through close collaboration with our supplier and channel partners.

Initiatives included:

  • Increasing production output, addressing technical issues and improving production line efficiency to increase plastic vial output at our vendor.
  • Streamlining quality testing and approval turnaround times.
  • Expediting delivery of vials from the supplier to our production facility.
  • Extending the shelf life of certain products by 30 days as an interim step.
  • Adding glass vials to help fill gaps from lower plastic vial production.

The supply recovery has been accelerated through the cooperation of many customers who have temporarily converted to using glass vials after we re-introduced BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass. For customers who are able to take advantage of this temporary solution we provided guidance, including verification protocols, on how to adapt their internal systems to utilize glass vials. Continued utilization of glass is critical to long-term supply recovery.

We continue to press ahead with a full range of actions to replenish inventory and safety stock in time to meet critical seasonal testing demand. We’ve successfully managed through two major weather events recently and were able to maintain supply continuity with minimal impact on customers, despite some short-term disruption to our transportation and shipping capacity.

Going forward we will continue working with our channel partners to close the gap and align with customer needs. To help with this we recently asked our distributors to evaluate orders older than 30 days and consider cancelling aged and large backorders so current orders take priority. Our goal is to ensure that customer’s most acute current needs are addressed.

While every customer situation is unique, we are committed to regular ongoing collaboration with distributors and customers. We appreciate the patience and cooperation of all our customers and distribution partners.

will continue to post new information and updates to this website through the end of the year. If you haven’t done so already, please register with the form below to receive updates. And don’t hesitate to contact your BD sales representative with questions or contact our dedicated BD BACTEC™ hotline at 1.888.834.4332.

NEW/UPDATED as of October 8, 2024

Supply management

What is the cause of the BD BACTEC™ Media shortage? (August 23, 2024)
Our vial supplier began to experience technical challenges with production that constrained our ability to produce BD BACTEC™ blood culture vials during peak demand periods starting in early 2024. BD immediately began working with the blood culture vial supplier through the ensuing months to ensure corrective actions were taken to improve production efficiency and increase vial output.
The availability of plastic has not played a role in BD BACTEC™ plastic vial supply challenges, and our vendor has not shut down any production lines other than for short periods of preventative or necessary maintenance. We are experiencing a decrease in production from our supplier of plastic vials.

We now expect to get production levels back to meeting 100% of historic demand levels by end of September for the U.S. market. And by the end of 2024, we expect to produce 125% of historical weekly demand to enable distributors and customers in the U.S. to begin rebuilding inventory and safety stock. 

By the end of September. We are focused on maintaining product allocations for the U.S. going forward to meet historical weekly demand.
We are currently in production for both plastic and glass vials for the BD BACTEC™ Lytic/10 Anaerobic/F Culture and our production levels are improving monthly. We are asking our U.S. customers move to glass as much as possible to accelerate the increase of inventory levels. The adoption of glass helps the overall supply situation and inventory levels improve more quickly. We are confident improvement will continue steadily and our commitment to customers to transparently track progress on our website.

Because of the complexities associated with our manufacturing and shipping process, we cannot provide universal guidance on allocation that would be accurate for all labs.  Please contact our dedicated BD BACTEC™ hotline at 1.888.834.4332 or your BD Account Executive using the “Contact Us” form at the bottom of this tab for the latest and most accurate information about your open orders.

Yes. We will continue to support all customer needs through our distribution channels and will dropship product to customers as necessary to meet urgent needs.

These plastic vials are only used in the production of BD BACTEC™ blood culture vials and do not impact production of other BD products. Please see list of impacted products below.

Other regions are also experiencing supply challenges.

Yes. Based on internal stability data, BD has issued an interim shelf-life extension for specific lots of  BD BACTEC™ Plus Aerobic, Plus Anaerobic, Lytic Anaerobic, and Peds Plus SKUs in the United States. Details of specific products included in this communication can be found on the “Resources” tab.

BD uses strict testing standards in line with product and design requirements to assign shelf-life for each of its products. As a global manufacturer, careful consideration is required to account for broad coverage of targeted organisms, the environments where our products may be used, and variations in logistic pathways.

The current process for establishing shelf-life for regulated devices includes obtaining a successful time point beyond the claimed expiry time-period and recently this data has been used as supporting evidence to grant an interim extension to 10 months for specific lots.

While we are aware of published data that suggests that some blood culture media may, under certain conditions and for certain pathogens, meet requirements beyond the stated shelf-life, products in the market are expected to meet all design input requirements. BD has looked at expanding shelf-life for BACTEC™ media as it has many positive benefits for both BD and our customers, however our internal data does not support broad extensions beyond what we have determined for each specific lot at this time.

Production schedules for blood culture media are regularly updated to ensure optimal product mixes based on regional demands.

Please use the “Contact Us” form at the bottom of this tab and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.

Laboratory and clinical management

Is FDA approval or validation required for using glass media on patients? (September 26, 2024)

The BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vials was previously cleared by FDA under the same name prior to the BD BACTEC™ Lytic/10 Anaerobic/F Culture being made in plastic vials. Although the BD BACTEC™ Lytic Anaerobic glass vial product is a different SKU (#442265), there are no changes in the intended use or media formulation of the product when compared to plastic.

As a manufacturer, we cannot recommend or say if you need a verification to utilize the glass vials versus the plastic vials. The requirement and choice of a verification strategy for the BD BACTEC™ Blood Culture media is ultimately the decision of the laboratory.

No.

The CMS Division of Clinical Improvement and Quality (DCLIQ) is responsible for the oversight of clinical laboratories and laboratory testing.  DCLIQ is aware of the BD BACTEC™ blood culture media vial supply challenges.  For hospital sepsis quality metric questions, please contact [email protected] for assistance.

Per CMS, “when the laboratory introduces an unmodified, FDA-cleared or approved test system, it must conduct a verification of performance specification study.” Your regulatory entity would be best positioned to help answer any questions you have on verification and or validation requirements.

Per CMS, “when the laboratory introduces an unmodified, FDA-cleared or approved test system, it must conduct a verification of performance specification study.” Your regulatory entity would be best positioned to help answer any questions you have on verification and or validation requirements.
On our website under “Resources” is a letter addressing BD BACTEC™ Lytic Anaerobic media in glass equivalency. Although the glass vial product is a different SKU, there are no changes in the intended use or the media formulation when compared to plastic and therefore, clinical differences would not be expected.

One set can be collected in one plastic vial and one glass vial. The BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vial has the same intended use as the plastic vial.

We define a “set” as having an anaerobic and an aerobic vial, not by them being glass or plastic.

As a manufacturer, we cannot make recommendations on what is the minimum number of organisms needed. We created our suggested verification protocol keeping in mind regulatory requirements from CAP and CLIA. Your regulatory entity would be best positioned to help answer any questions you have on verification protocols.

Please use the “Contact Us” form at the bottom of this tab and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.

Lytic glass

Is BD bringing back glass vials? (September 2, 2024)
Yes. As an additional mitigation measure, we are launching the BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442265) in glass only in the United States and select countries in Europe1 based on registration status. This was a product we previously discontinued but are now reintroducing to supplement and improve the overall supply of media worldwide until our plastic supplier can resolve their challenges. Availability is expected at the beginning of September for the US and the beginning of October for Europe. Please see the “Now Available” letter for communication in the USA. Additional communication on glass can be found on the “Resources” tab.
BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442265) in glass will only be available in the United States  and  select countries in Europe1. Please see the “Now Available” letter for communication in the USA. Additional communication on glass can be found on the “Resources” tab.
We recommend that you order both Lytic Anaerobic media in glass (442265) and plastic (442021) We expect that you will receive a mixture of both BD BACTEC™ Lytic/10 Anaerobic/F Culture SKUs in the coming months. Please be sure to indicate specific SKUs for plastic and glass. Information about ordering, verification and equivalency are available in the “Resources” section of this website.

Customers who live in the United States and select countries in Europe1 where lytic anaerobic media in glass is available, must place separate orders for these products under SKU #442265.  

442265

No. Lytic anaerobic media in both glass (SKU #442265) and plastic (SKU #442021) will continue to be offered. We are reintroducing lytic anaerobic media in glass to improve overall media availability, allowing for more manufacturing of plastic vials for other SKUs. When we are able to return to full plastic supply and healthy customer inventories we plan to discontinue the manufacturing of glass.

Supplier shipments of plastic vials have steadily improved since the beginning of July through early September with a 57 percent increase in shipments to BD. We will continue to provide updates on performance and when appropriate will communicate the return to glass. At this time, we anticipate glass vials to be available through January 2025.
Plastic vials of BD BACTEC™ Lytic/10 Anaerobic/F Culture will still be available. We are shipping both plastic and glass vials for lytic and anaerobic media.

The CLIA categorization for the BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442265) in glass is moderate complexity and is the same complexity as the BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials (SKU #442021) in plastic.

Based on our current manufacturing capabilities, we can most quickly launch the BD BACTEC™ Lytic Anaerobic media in glass (SKU #442265). Other media types require more specialized manufacturing processes which would take longer to deploy and given the urgent nature of the current supply situation we are looking to expedite product availability.  By re-launching BD BACTEC™ Lytic Anaerobic media in glass (SKU #442265), we expect to improve overall quantities of all products including our BD BACTEC™ Plus Aerobic media (SKU #442023) and BD BACTEC™ Peds Plus media (SKU #442020).

The BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vials are a temporary solution and we have introduced it to enable us to improve inventory levels. We do not have plans for any other media in glass, it is only for the BD BACTEC™ Lytic/10 Anaerobic/F Culture media.

There are distinct differences in media formulation and organism recovery between the media that should be considered before switching media types.

From a manufacturing standpoint, we believe the supply for the BD BACTEC™ Lytic anaerobic vial in glass is enough to supply the U.S. region so there is no need to move media types.

Although the glass vial is a different SKU (#442265), there are no changes in the intended use of the product when compared to plastic. The glass vial is slightly taller but otherwise has the same dimensions to fit into BD BACTEC™ instruments. BD BACTEC™ instruments can run both plastic and glass vials simultaneously with no software configurations necessary. Users will have to consider the implications of glass vial when using their pneumatic tube system. BD offers a bottle holder (SKU #445771) to help protect glass vials during transport. For a copy of the IFU, please see the “Resources” tab.
No. There are no plans to launch other BD BACTEC™ blood culture media types in glass as we expect this to be a short-term measure while we resolve the issues with our plastic vial supplier.  We will return to 100% plastic vials at the earliest opportunity based on consistent supply of plastic vials from our supplier.  We will provide clear timelines as they become available. Please check the “Overview” tab for the latest information.

There has been no disruption to pediatric vial production. We are managing Pediatric vial production similar to all other media types. BD BACTEC™ Pediatric media will not be available in glass.

We can manufacture the BD BACTEC™ Lytic/10 Anaerobic/F Culture media in glass without disruption to our automated lines for plastic. Lytic in glass in a semi-automated production process. One of the reasons we can do this is because there are no resins in the BD BACTEC™ Lytic/10 Anaerobic/F Culture media, which makes it a much easier media for us to manufacture on a semi-automated basis, without impacting our automated production lines. We do not plan to move to glass for any other media.

As a manufacturer, we cannot make recommendations on the need for verification and instead would defer to your laboratory’s specific Standard Operating Procedure (SOP).  For additional questions regarding verification requirements please contact CMS at [email protected]. For our suggested verification protocols, please visit the “Resources” tab.

For customers migrating to BD BACTEC™ Lytic Anaerobic media in glass, one case (100 holders of BD BACTEC™ Holders (SKU# 445771)) has been provided at no charge. To order additional BD BACTEC™ Holders, please contact your BD sales representative.

The shelf-life for glass and plastic vials is the same.

Yes. Performance data including time to detection and percent recovery between glass and plastic lytic anaerobic media are available in the glass equivalency letter.

Users will have to consider the implications of glass vials when using pneumatic tube systems, however, BD offers a bottle holder (SKU #445771) to help protect glass vials during transport.

BD BACTEC™ Myco F Lytic in glass (SKU #442288) will be discontinued in markets where Myco F Lytic media in plastic (SKU #442794) is available. Discontinuing Myco F Lytic in glass will enable us to streamline our operations and focus manufacturing on improving overall media production. Laboratories with access to Myco F Lytic media in plastic should plan appropriately for this transition by ensuring that any verification requirements have been completed.  

Please use the “Contact Us” form at the bottom of this tab and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.

1European countries include Spain, Denmark, United Kingdom, Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hungary, Ireland, Italy, Martinique, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden

BD BACTEC™ Bottle Holder

What is the BD BACTEC™ Bottle Holder? (September 18, 2024)

The BD BACTEC™ Bottle Holder is an accessory to aid in transport of glass vials, primary through pneumatic tube systems.

No. The BD BACTEC™ Bottle Holder is considered an accessory and not required for use with glass blood culture vials.

As an accessory product, the BD BACTEC™ Bottle Holder does not have associated instructions for use.

To reduce the risk of biohazardous exposure, laboratories may choose to place the bottle holder containing the blood culture vial into a biohazard bag with a zip enclosure. The BD BACTEC™ Bottle Holder should be immobilized inside the pneumatic tube carrier using padded inserts or liners to cushion the sample during transfer.

Yes, the BD BACTEC™ Bottle Holder is reusable. It is designed for multiple transport cycles; however, the holder should be regularly inspected for signs of damage or loss of integrity, particularly around the screw top, to ensure its longevity.

The BD BACTEC™ Bottle Holder is made from a high-impact resistant polypropylene copolymer. 

Customers can be advised to follow the CDC’s Guideline for Disinfection and Sterilization in Healthcare facilities for low-level items with a smooth, hard surface (Table 1A). This includes options like using 70% isopropyl alcohol (contact time of <1 minute) or quaternary ammonium chloride/alcohol-based solution (such as a Super Sani-Cloth® Germicidal Disposable Wipe, which has a 2-minute contact time).  Frequency of disinfecting may be at the discretion of a facility’s own infection control department.

If a glass vial breaks while in the BD BACTEC™ Bottle Holder, the holder may provide an extra layer of protection, but we cannot guarantee it will contain all spills in every circumstance. To help contain leaks, it is recommended that the bottle holder containing the specimen is placed in a biohazard bag with a zip closure.

Please use the “Contact Us” form on BDBACTEC-UPDATE.com and we will route your question to the appropriate BD representative. We have also established a dedicated BD BACTEC™ support team to help answer both supply chain and clinical questions. Call 1.888.834.4332 to connect to the BD BACTEC™ support team.

Contact Us

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BD BACTEC™ blood culture vials, or if you would like to receive updates when this website is updated.
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