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.
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.
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.
The CD11b APC product can produce weak fluorescence signals during cell staining. This may cause false negative results, leading to misdiagnosis of blood cancers, delayed treatment, and additional patient samples.
Lab users and healthcare professionals who test blood samples with these CD11b APC products. Those at highest risk are patients with hematological malignancies needing accurate cancer diagnosis.
Check for reference numbers 340936 or 333143 on the product label. Products with expiration dates up to February 28, 2025, are affected.
Look for reference numbers 340936 or 333143 on the product label.
The product may cause low or dim fluorescence signals, leading to false negative results, misdiagnosis of blood cancers, delayed treatment, and additional patient samples.
Check for reference numbers 340936 or 333143 on the product label. Products with expiration dates up to February 28, 2025, are affected.
The recall does not require stopping use; it is a low-risk issue that may affect test accuracy.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0641-2024 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0641-2024 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.
