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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 September 2, 2024
What’s new

A message from BD leadership

  • 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.
  • While supply is tight right now, we have made strong progress over the last 60 days.
  • We know that many of you are still facing shortages as production catches up.
  • We expect to meet 100% of historical demand by the end of September. By the end of 2024, we are striving to be at 125% of historical demand.

BD BACTEC™ update

This website contains the latest information about the supply of BD BACTEC™ blood culture vials for the U.S. market.

BD has worked diligently with our supplier to increase production output, addressing technical issues and improving production line efficiency to increase plastic vial output. We implemented a range of efficiency measures, including streamlining quality testing and approval turnaround times, expediting delivery of vials from the supplier to our production facility, and extending the shelf life of certain products by 30 days in the interim.

To add supplemental capacity, we have temporarily re-introduced production of BD BACTEC™ Lytic/10 Anaerobic/F Culture in glass vials. It is imperative we get as many customers as possible to convert temporarily to glass vials.

These efforts are having a positive effect, and we are experiencing greater output from our supplier and more product entering the market. We are working closely with our distributors to align with our customers’ needs and minimize the time gap between receiving product from BD and distribution to customers.

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.

It is important to understand that reaching that level of supply requires as many U.S. customers as possible to use Lytic glass vials when they can.

Complete the form below to receive notices of updates. As always, feel free to reach out to your BD sales representative with questions or contact our dedicated BD BACTEC™ hotline at 1.888.834.4332.

FAQs

Supply management
Laboratory and clinical management
Lytic glass

NEW/UPDATED as of September 2, 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.

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. 

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.

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.

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 CMS considering relaxing some of the current requirements around blood culture collection during this supply crisis? (August 23, 2024)
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.

The formulation for each BD BACTEC™ blood culture vial is carefully determined to best meet the intended use of each product (e.g., optimal growth environment for anaerobic or aerobic organisms). In addition to different media formulations, anaerobic and aerobic media types differ in the composition of the vials’ atmospheric headspace to optimize growth of targeted organisms.

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

UPDATED 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.

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.  

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.

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).

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.
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.
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

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