Lower risk Medical device recall · FDA · Published October 25, 2023

BD Biosciences CD11b APC: Low fluorescence may cause misdiagnosis

BD Biosciences recalls CD11b APC products that may cause low fluorescence signals, leading to false negatives and misdiagnosis of blood cancers. Affected products have specific reference numbers and expiration dates.

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

🇺🇸 FDA recall #Z-0641-2024Medical device BD Biosciences ›

Lower-risk recall

In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

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 CD11b APC products that can cause low or dim fluorescence signals during blood cancer testing. This may lead to false negative results, misdiagnosis, delayed treatment, and extra patient samples. Read more at govinfonow.com/recall/57006-bd-biosciences-cd11b-apc-low-fluorescence-may-cause-misdiagnosis.

Source Summary by GovInfoNow · govinfonow.com/recall/57006-bd-biosciences-cd11b-apc-low-fluorescence-may-cause-misdiagnosis · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0641-2024

Cite this page

“BD Biosciences CD11b APC: Low fluorescence may cause misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57006-bd-biosciences-cd11b-apc-low-fluorescence-may-cause-misdiagnosis. Based on FDA recall #Z-0641-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0641-2024%22&limit=1).

The FDA announced on Oct. 25, 2023, that BD Biosciences is recalling CD11b APC reagents due to potential false negative results in hematological malignancy diagnoses. The agency issued the voluntary Class II recall after identifying quality issues affecting cell staining.

How to tell if you have it

Brand: BD Biosciences
Product: CD11b APC: ASR, REF: 340936; CE, REF: 333143
Lot/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
Quantity: 464 Vials

The hazard

GovInfoNow's records show the in vitro diagnostics product can cause low or dim fluorescence signals. This defect may lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.

Context

GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has 10 other recalls on record since May 16, 2018. Other recent recalls of similar products include BD Multitest 6-Color TBNK Kit (May 8, 2024), BD Trucount Tubes Recall (Oct. 3, 2022), and BD Anti-Kappa APC Reagent Recall (March 25, 2022). Other recent recalls of similar products include TECHNO-PATH Multichem ID-B Serum Recall (Oct. 17, 2025), TECHNO-PATH Multichem ID-B Recall (Oct. 17, 2025), and Siemens Atellica CH A1c_E Hemoglobin Test (Feb. 23, 2026).

How to tell if you have this one

Check for reference numbers 340936 or 333143 on the product label. Products with expiration dates up to February 28, 2025, are affected.

Brand
BD Biosciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for reference numbers 340936 or 333143 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

FDA distribution: “Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington.

Recall timeline

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

Oct 25, 2023Firm started the recall
Jan 5, 2024FDA classified it Class II
Jan 17, 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

Do I need to stop using the product?

The recall does not require stopping use; it is a low-risk issue that may affect test accuracy.

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Link to this recall

<a href="https://govinfonow.com/recall/57006-bd-biosciences-cd11b-apc-low-fluorescence-may-cause-misdiagnosis">BD Biosciences CD11b APC: Low fluorescence may cause misdiagnosis (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-0641-2024 (October 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0641-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.