Becton, Dickinson and Company, BD Biosciences: BD Multitest Reagents Recalled Due to Compromised Raw Material

Agency Publication Date: July 12, 2024

Summary

Becton, Dickinson and Company (BD Biosciences) is recalling approximately 10,027 units of its BD Multitest 6-Color TBNK reagents and kits. These medical diagnostic tools, used to assess a patient's immune system status, were manufactured with compromised raw materials that can cause contaminated antibodies. This defect can lead to unusual staining patterns or high background noise in laboratory tests, potentially resulting in erroneous or delayed medical results and requiring patients to provide additional blood samples. The affected products were distributed across 34 U.S. states and several international locations between July and September 2024.

Risk

The compromised material can cause the laboratory equipment to produce inaccurate data or 'double positive' events. This may lead healthcare providers to make incorrect clinical decisions or delay necessary treatments while waiting for re-testing.

What You Should Do

Identify if you have the affected BD Multitest products by checking the REF and Lot numbers on the packaging: BD Multitest 6-Color TBNK CE-IVD (REF 644611, Lots 20010, 49510, 32674) or BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD (REF 337166, Lots 17569, 22709, 49517).
Check for additional affected products: BD Multitest 6-Color TBNK IVD (REF 662967, Lots 17572, 17582, 26797, 69761, 49506) or BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD (REF 662995, Lot 49508).
Confirm the expiration dates for these lots, which range from July 31, 2024, to September 30, 2024.
If you possess any of the affected lot numbers, contact your healthcare provider or Becton, Dickinson and Company (BD Biosciences) for specific instructions on how to handle the compromised materials.
Laboratories and healthcare facilities should review recent test results generated with these lots to determine if clinical decisions were impacted and if patient re-sampling is necessary.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this recall.

Your Remedy Options

Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Multitest 6-Color TBNK CE-IVD

Model / REF:

644611

UPC Codes:

382906446114

Lot Numbers:

20010 (Exp 31-Aug-24)

49510 (Exp 30-Sep-24)

32674 (Exp 30-Sep-24)

Date Ranges: 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD

Model / REF:

337166

UPC Codes:

382903371662

Lot Numbers:

17569 (Exp 31-Jul-24)

22709 (Exp 31-Aug-24)

49517 (Exp 30-Sep-24)

Date Ranges: 31-Jul-24, 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK, IVD

Model / REF:

662967

UPC Codes:

382906629678

Lot Numbers:

17572 (Exp 31-Jul-24)

17582 (Exp 31-Jul-24)

26797 (Exp 31-Aug-24)

69761 (Exp 30-Sep-24)

49506 (Exp 30-Sep-24)

Date Ranges: 31-Jul-24, 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD

Model / REF:

662995

UPC Codes:

382906629951

Lot Numbers:

49508 (Exp 30-Sep-24)

Date Ranges: 30-Sep-24

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94830

Status: Active

Manufacturer: Becton, Dickinson and Company, BD Biosciences

Sold By: Direct distribution to laboratories and healthcare facilities

Manufactured In: United States

Units Affected: 10,027

Distributed To: Minnesota, New Jersey, New York, Maryland, Utah, Florida, North Carolina, Massachusetts, Kentucky, Nebraska, Nevada, California, Louisiana, District of Columbia, Ohio, Michigan, Pennsylvania, Washington, Connecticut, Alabama, Delaware, Tennessee, Indiana, Oregon, Illinois, Wisconsin, New Hampshire, Texas, Georgia, Rhode Island, South Dakota, Idaho, New Mexico, Arkansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected BD Multitest products by checking the REF and Lot numbers on the packaging: BD Multitest 6-Color TBNK CE-IVD (REF 644611, Lots 20010, 49510, 32674) or BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD (REF 337166, Lots 17569, 22709, 49517).

Check for additional affected products: BD Multitest 6-Color TBNK IVD (REF 662967, Lots 17572, 17582, 26797, 69761, 49506) or BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD (REF 662995, Lot 49508).

Confirm the expiration dates for these lots, which range from July 31, 2024, to September 30, 2024.

If you possess any of the affected lot numbers, contact your healthcare provider or Becton, Dickinson and Company (BD Biosciences) for specific instructions on how to handle the compromised materials.

Laboratories and healthcare facilities should review recent test results generated with these lots to determine if clinical decisions were impacted and if patient re-sampling is necessary.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this recall.

Affected Products

Product: BD Multitest 6-Color TBNK CE-IVD

Model / REF:

644611

UPC Codes:

382906446114

Lot Numbers:

20010 (Exp 31-Aug-24)

49510 (Exp 30-Sep-24)

32674 (Exp 30-Sep-24)

Date Ranges: 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD

Model / REF:

337166

UPC Codes:

382903371662

Lot Numbers:

17569 (Exp 31-Jul-24)

22709 (Exp 31-Aug-24)

49517 (Exp 30-Sep-24)

Date Ranges: 31-Jul-24, 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK, IVD

Model / REF:

662967

UPC Codes:

382906629678

Lot Numbers:

17572 (Exp 31-Jul-24)

17582 (Exp 31-Jul-24)

26797 (Exp 31-Aug-24)

69761 (Exp 30-Sep-24)

49506 (Exp 30-Sep-24)

Date Ranges: 31-Jul-24, 31-Aug-24, 30-Sep-24

Product: BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD

Model / REF:

662995

UPC Codes:

382906629951

Lot Numbers:

49508 (Exp 30-Sep-24)

Date Ranges: 30-Sep-24

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94830

Status: Active

Manufacturer: Becton, Dickinson and Company, BD Biosciences

Sold By: Direct distribution to laboratories and healthcare facilities

Manufactured In: United States

Units Affected: 10,027