BD Biosciences recalls specific BD FACSLyric Flow Cytometers (serial numbers R651165000010-R651165000060) when used with BD Trucount Tubes due to potential false high cell counts affecting medical treatments.
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 certain 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 needing precise blood cell measurements.
The flow cytometer may record too many electronic aborts when processing blood samples in specific tubes, causing false high cell counts. This could lead to wrong treatment decisions for HIV patients and others needing precise blood cell measurements.
Laboratory users and healthcare professionals who operate the recalled flow cytometers with BD Trucount Tubes. Patients relying on accurate cell counts for treatment decisions are at risk of incorrect medical outcomes.
Check if your BD FACSLyric Flow Cytometer has serial numbers starting with R651165000010 to R651165000060. The issue occurs only when using BD Trucount Tubes.
Verify your flow cytometer's serial number starts with R651165000010 to R651165000060.
Do not use the recalled flow cytometer with BD Trucount Tubes until a replacement is confirmed.
The flow cytometer may record excessive electronic aborts when used with specific tubes, leading to inaccurate cell counts that could affect medical treatments.
It may cause falsely high cell counts, which could lead to incorrect medical decisions for HIV patients and others needing precise blood cell measurements.
Check if your BD FACSLyric Flow Cytometer has serial numbers starting with R651165000010 to R651165000060.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0071-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0071-2020 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.
