BD Biosciences recalls BD FACSLyric Flow Cytometers (serials Z662877000001-0008) when used with BD Trucount Tubes. Excessive electronic abort counts may cause inaccurate cell counts, affecting HIV treatment and lab results.
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 lab results.
The flow cytometer may register excessive electronic abort counts (over 1.0% of processed events) when used with specific tubes. This can cause falsely high cell counts, potentially leading to incorrect medical decisions for HIV patients and lab results.
Laboratory users and healthcare professionals who operate the BD FACSLyric Flow Cytometer with BD Trucount Tubes. HIV patients and immunocompromised individuals are most at risk of inaccurate treatment decisions.
Check for BD FACSLyric Flow Cytometer serial numbers starting with Z662877000001 to Z662877000008. The recall applies only when using BD Trucount Tubes.
Look for serial numbers starting with Z662877000001 to Z662877000008 on the instrument.
The flow cytometer may register excessive electronic abort counts when used with BD Trucount Tubes, which can cause inaccurate cell counts and affect medical decisions.
Incorrect cell counts could lead to improper initiation of prophylactic therapy for HIV patients, potentially affecting their treatment.
No, but you should check if you have the recalled serial numbers and avoid using BD Trucount Tubes with this model until the issue is resolved.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0068-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0068-2020 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.
