Lower risk Medical device recall · FDA · Published May 8, 2024

BD Multitest 6-Color TBNK Kit: Risk of Erroneous Lab Results

BD Biosciences recalls specific BD Multitest 6-Color TBNK kits due to potential for inaccurate immune system test results, which could lead to incorrect healthcare decisions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2351-2024Medical device BD Biosciences ›

Lower-risk recall

Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

Take action

Contact the company

Recalling firmBecton, Dickinson and Company, BD Biosciences2350 Qume Dr · San Jose, CA 95131-1812

✎ GovInfoNow plain-language explainer

BD Biosciences is recalling certain BD Multitest 6-Color TBNK kits and associated reagents because they may produce inaccurate immune system test results. This could lead to incorrect healthcare decisions if used in lab testing. Read more at govinfonow.com/recall/55154-bd-multitest-6-color-tbnk-kit-risk-of-erroneous-lab.

Source Summary by GovInfoNow · govinfonow.com/recall/55154-bd-multitest-6-color-tbnk-kit-risk-of-erroneous-lab · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2351-2024

Cite this page

“BD Multitest 6-Color TBNK Kit: Risk of Erroneous Lab Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55154-bd-multitest-6-color-tbnk-kit-risk-of-erroneous-lab. Based on FDA recall #Z-2351-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2351-2024%22&limit=1).

The FDA announced on May 8, 2024, that Becton, Dickinson and Company is recalling BD Biosciences Multitest kits due to compromised raw materials that may lead to erroneous or delayed results. The agency issued recall number Z-2351-2024 for the voluntary Class II action.

How to tell if you have it

BD Multitest 6-Color TBNK CE-IVD, REF: 644611
BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166
BD Multitest 6-Color TBNK, IVD, REF: 662967
BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995

The hazard

The Multitest kits contain compromised raw material that may result in flow cytometry plots with unusual staining patterns, nonspecific aggregates, high background, or contaminated antibodies. These defects can lead to erroneous or delayed results and might impact healthcare decisions.

Context

GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has 10 other recalls on record since 2018-05-16. Other recent recalls of similar products include BD Biosciences CD11b APC (2023-10-25), BD Trucount Tubes (2022-10-03), and BD Anti-Kappa APC Reagent (2022-03-25). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit (2026-06-04), and TECHNO-PATH Multichem ID-B (2025-10-17).

How to tell if you have this one

Check for the product reference numbers: 644611, 337166, 662967, or 662995. These kits were sold with specific expiration dates and lot numbers listed in the recall notice.

Brand
BD Biosciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product reference number on the kit or reagent packaging to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed in 33 states and D.C..

FDA distribution: “US: MN, NJ, NY, MD, UT, FL, NC, MA, KY, NE, NV, CA, LA, DC, OH, MI, PA, WA, CT, AL, DE, TN, IN, OR, IL, WI, NH, TX, GA, RI, SD, ID, NM, AR. OUS: CA, SG, NZ, AU, KR, IN, PE, GT, AR, MX, TW, CN, NI, CR, JP, BR, TH, BE, VN” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA published this recall 3 months after the firm started it.

May 8, 2024Firm started the recall
Jul 12, 2024FDA classified it Class II
Jul 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any risks to users?

The recall is for potential inaccurate test results, not direct harm to users. The risk is low and relates to lab accuracy, not patient safety.

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Link to this recall

<a href="https://govinfonow.com/recall/55154-bd-multitest-6-color-tbnk-kit-risk-of-erroneous-lab">BD Multitest 6-Color TBNK Kit: Risk of Erroneous Lab Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2351-2024 (May 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2351-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.