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.
Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.
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.
The product may show unexpected cell populations with dim CD3 expression, which can cause inaccurate results during immunophenotyping. This could lead to incorrect medical decisions if used in flow cytometry procedures.
Users of immunophenotyping flow cytometry tests who have the specific BD Multi-Check CD4 Low Control 2.5 mL IVD product. Laboratory staff and researchers handling blood samples for immune cell analysis are most at risk.
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.
Look for lot numbers BM1020L or the specific catalog numbers listed in the recall notice.
The product may show unexpected cell populations with dim CD3 expression, which can cause inaccurate results in immunophenotyping tests.
Check the product lot number and catalog numbers to see if it's affected. If it is, contact BD Biosciences for further instructions.
The recall notice does not specify a remedy, but you should check the product lot number and contact BD Biosciences if you have the affected product.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0562-2021 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0562-2021 from BD Biosciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
