BD Biosciences recalls Analyte specific reagent due to false positive reactions. Affected units have REF/UDI codes listed. Users should stop using to avoid inaccurate test results.
False positive reaction on the reagent.
BD Biosciences is recalling Analyte specific reagent (CD45 APC-H7) because it can cause false positive reactions in flow cytometry tests. This could lead to incorrect cell identification results in laboratory settings.
The reagent can produce false positive reactions when used in flow cytometry tests, leading to incorrect identification of CD45 antigen-expressing cells. This may cause misdiagnosis or incorrect data interpretation in laboratory settings.
Laboratory users who have the affected reagent for in vitro diagnostic testing. Researchers and medical professionals using flow cytometers with this reagent are most at risk of inaccurate results.
Check for REF/UDI codes: 641408/641408-4012-1-1 (US), 641417/641417-1157-1-01 (OUS), or 641399/641399-4012-1-01 (US Research Use Only). The product is BD CD45 APC-H7 reagent for flow cytometry.
Discontinue use of the affected reagent to prevent false positive reactions in flow cytometry tests.
BD CD45 APC-H7 reagent for flow cytometry tests.
US: 641408/641408-4012-1-1 and 641399/641399-4012-1-01; OUS: 641417/641417-1157-1-01.
The reagent can produce false positive reactions when used in flow cytometry tests, leading to incorrect identification of CD45 antigen-expressing cells.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1971-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-1971-2020 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.
