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.
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
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.
The recalled kits may contain compromised raw materials that cause flow cytometry plots to show unusual staining patterns, nonspecific aggregates, or high background noise. This can lead to inaccurate test results, such as false positives or negatives in immune system assessments, potentially affecting patient care decisions.
Healthcare labs and medical professionals who use these kits for immune system testing. The risk is primarily for labs that rely on these specific kits for accurate diagnostic results.
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.
Verify the product reference number on the kit or reagent packaging to confirm if it is recalled.
The kits may contain compromised raw materials that cause inaccurate immune system test results, potentially leading to incorrect healthcare decisions.
The recall notice does not specify a remedy, so check the product reference number to confirm if it is affected and contact BD Biosciences for further guidance.
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.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2351-2024 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-2351-2024 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.
