BD Biosciences recalls BD FACSLyric Flow Cytometers (serials Z662875000001-000018) when used with BD Trucount Tubes due to potential false high cell counts affecting medical decisions.
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
BD Biosciences is recalling specific BD FACSLyric Flow Cytometers that may give inaccurate cell counts when used with BD Trucount Tubes. This could lead to incorrect medical decisions for HIV patients and others with weakened immune systems.
Using these flow cytometers with BD Trucount Tubes can cause electronic abort counts to exceed 1.0% of processed events. This may result in falsely high cell counts, which could affect critical medical decisions like starting prophylactic therapy for HIV patients or managing immune-suppressed conditions.
Laboratory users and healthcare professionals who rely on this flow cytometer for blood cell analysis, particularly those working with HIV patients or immunocompromised individuals.
Check if your BD FACSLyric Flow Cytometer has a serial number starting with Z662875000001 to Z662875000018. The recall applies only when using BD Trucount Tubes.
Verify your flow cytometer's serial number starts with Z662875000001 to Z662875000018.
The flow cytometer may produce excessive electronic abort counts when used with BD Trucount Tubes, leading to falsely high cell counts that could affect medical decisions.
Check your flow cytometer's serial number. If it starts with Z662875000001 to Z662875000018, contact BD Biosciences for guidance.
The recall applies only when using BD Trucount Tubes. If you don't use these tubes, the product may be safe.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0066-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0066-2020 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.
