BD Biosciences recalls specific BD FACSLyric Flow Cytometers used with Trucount Tubes due to potential false high cell counts affecting patient care 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 certain BD FACSLyric Flow Cytometers when used with BD Trucount Tubes. This can cause inaccurate cell counts that might lead to incorrect medical decisions for HIV patients and others with weakened immune systems.
The flow cytometer may show excessive electronic abort counts when used with specific tubes, leading to falsely high cell counts. This could cause incorrect medical decisions, such as improper treatment for HIV patients or immunocompromised individuals.
Laboratory users, particularly those in medical research or clinical settings handling HIV patients and immunocompromised individuals. The risk is low for most users but could affect critical medical decisions if the instrument is misused.
Check for BD FACSLyric Flow Cytometer serial numbers starting with Z662878000003 to Z662878000123 (excluding Z662878000048). The recall applies only when using BD Trucount Tubes.
Verify if your BD FACSLyric Flow Cytometer has a serial number in the list provided by the manufacturer.
The flow cytometer may experience excessive electronic abort counts when used with specific tubes, which could lead to inaccurate cell counts affecting medical decisions.
Check if your instrument's serial number is in the list provided by the manufacturer. If it is, contact BD Biosciences for guidance.
This is a potential accuracy issue, not a safety hazard. The risk is low and only affects medical decisions if the instrument is misused.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0069-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0069-2020 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.
