BD Biosciences recalls specific BD FACSLyric Flow Cytometers when used with BD Trucount Tubes due to potential false high cell counts affecting patient care decisions 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 false high cell counts when used with BD Trucount Tubes. This could lead to incorrect medical decisions for HIV patients and other immunocompromised individuals, as well as inaccurate lab results.
The flow cytometer may record excessive electronic abort counts when using specific tubes, causing false high absolute cell counts. This can lead to incorrect medical decisions for HIV patients and immunocompromised individuals, as well as inaccurate laboratory results.
Laboratory users and healthcare professionals who operate the recalled flow cytometers with BD Trucount Tubes. Patients receiving HIV treatment or immunocompromised care are at risk of incorrect medical decisions based on faulty cell counts.
Check if your BD FACSLyric Flow Cytometer has the serial numbers listed in the recall notice (R654587000008 to R654587000048 and Z654587P027). The recall applies only when using BD Trucount Tubes.
Verify if your flow cytometer has a serial number in the list: R654587000008 to R654587000048 or Z654587P027.
The flow cytometer may record excessive electronic abort counts when used with BD Trucount Tubes, potentially causing false high cell counts that could affect medical decisions for HIV patients and immunocompromised individuals.
Check if your flow cytometer has a serial number in the list provided in the recall notice. If it does, stop using it with BD Trucount Tubes until a replacement is obtained.
Incorrect cell counts could lead to improper initiation of HIV treatment or other medical decisions for immunocompromised patients, as well as inaccurate laboratory results.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0072-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0072-2020 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.
