Lower risk Medical device recall · FDA · Published October 5, 2020

BD Multi-Check CD4 Low Control: Inaccurate Results Risk

BD Biosciences recalls Multi-Check CD4 Low Control 2.5mL IVD due to potential inaccurate results from unexpected cell population dim CD3 expression. Affected lots include BM1020L and others.

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

🇺🇸 FDA recall #Z-0562-2021Medical device BD Biosciences ›

Lower-risk recall

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

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 its Multi-Check CD4 Low Control 2.5 mL IVD product because it may cause inaccurate results in immunophenotyping tests. This could lead to incorrect medical decisions if used in flow cytometry procedures. Read more at govinfonow.com/recall/64124-bd-multi-check-cd4-low-control-inaccurate-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64124-bd-multi-check-cd4-low-control-inaccurate-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0562-2021

Cite this page

“BD Multi-Check CD4 Low Control: Inaccurate Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64124-bd-multi-check-cd4-low-control-inaccurate-results-risk. Based on FDA recall #Z-0562-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0562-2021%22&limit=1).

The FDA announced on Oct. 5, 2020, that Becton, Dickinson and Company, BD Biosciences voluntarily recalled BD Multi-Check CD4 Low Control due to potential inaccurate results gating. The recall affects 619 vials distributed worldwide.

How to tell if you have it

Brand: BD Biosciences
Product: BD Multi-Check CD4 Low Control 2.5 mL IVD
Lot Number: BM1020L
Catalog Numbers (US): 349703, 349704, 349705
Catalog Numbers (OUS): 340914, 340915, 340916

The hazard

The FDA stated that recent product complaints showed an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. The record does not report specific incidents or injuries.

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 Multitest 6-Color TBNK Kit (2024-05-08), BD Biosciences CD11b APC (2023-10-25), and BD Trucount Tubes Recall (2022-10-03). Other recent recalls of similar products include Beckman Coulter Access Total T4 Calibrator Recall (2026-03-16), Cepheid Xpert BCR-ABL Ultra Test Kits (2025-10-30), and LH One Step Ovulation Test Device Recall (2025-11-22).

How to tell if you have this one

Check for lot numbers BM1020L or the catalog numbers 349703-349705 (US) and 340914-340916 (OUS) on the product label. The product is intended for use in immunophenotyping by flow cytometry.

Brand
BD Biosciences
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers BM1020L or the specific catalog numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 25 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Oct 5, 2020Firm started the recall
Dec 10, 2020FDA classified it Class II
Dec 16, 2020Published in FDA’s Enforcement Report
Mar 11, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/64124-bd-multi-check-cd4-low-control-inaccurate-results-risk">BD Multi-Check CD4 Low Control: Inaccurate Results Risk (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-0562-2021 (October 5, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0562-2021 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.