BD Biosciences recalls BD FACSLyric Flow Cytometers (serial numbers listed) when used with BD Trucount Tubes due to potential excessive electronic abort counts affecting 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 other immunocompromised individuals.
The flow cytometer may experience excessive electronic abort counts (beads exceeding 1.0% of processed events) when used with specific tubes. This can cause falsely high absolute cell counts, potentially leading to incorrect medical decisions like starting prophylactic therapy for opportunistic infections.
Laboratory users, particularly those working with HIV patients or immunocompromised individuals, who use the recalled flow cytometers with BD Trucount Tubes.
Check if your BD FACSLyric Flow Cytometer has a serial number listed in the provided list (e.g., 9180000057, 9180000219, etc.) or the reference numbers 659180 and 65918001. The device must be used with BD Trucount Tubes.
Verify if your flow cytometer's serial number is in the list provided by BD Biosciences (e.g., 9180000057, 9180000219, etc.).
The flow cytometer may experience excessive electronic abort counts when used with BD Trucount Tubes, which can lead to inaccurate cell counts and potentially incorrect medical decisions.
Check if your flow cytometer's serial number is in the provided list. If it is, stop using it with BD Trucount Tubes and contact BD Biosciences for further instructions.
The recall record does not specify a remedy, so no fix is provided. Users should check their serial numbers and contact BD Biosciences for guidance.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0073-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0073-2020 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.
