BD Biosciences recalls BD FACSLyric Flow Cytometers (REF: 662876) when used with BD Trucount Tubes due to potential false high cell counts affecting patient treatment 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 BD FACSLyric Flow Cytometers that may give false high cell counts when used with BD Trucount Tubes. This could lead to incorrect medical decisions for HIV patients and others needing precise cell counts.
The flow cytometer may show too many electronic abort counts when used with specific tubes, causing false high cell counts. This could lead to incorrect medical decisions like starting unnecessary treatments or missing critical care steps.
HIV patients and immunocompromised individuals who rely on precise cell counts for treatment decisions. Laboratory staff using these cytometers for blood tests may also be affected.
Check for BD FACSLyric Flow Cytometer serial number Z662876000007 or reference number 662876. The product is used with BD Trucount Tubes.
Verify the flow cytometer's serial number or reference number to confirm if it's affected.
The flow cytometer may show too many electronic abort counts when used with specific tubes, causing false high cell counts that could affect medical decisions.
It could lead to incorrect medical decisions for HIV patients and immunocompromised individuals, such as starting unnecessary treatments or missing critical care steps.
Check for BD FACSLyric Flow Cytometer serial number Z662876000007 or reference number 662876 when used with BD Trucount Tubes.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0067-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0067-2020 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.
