BD Biosciences recalls specific BD FACSLyric Flow Cytometers when used with BD Trucount Tubes due to potential false high cell counts affecting medical treatments 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 produce excessive electronic abort counts when used with specific BD Trucount Tubes, leading to falsely high cell counts. This can cause inaccurate results in medical treatments, such as initiating prophylactic therapy for opportunistic infections in HIV patients or managing immunocompromised patients.
Laboratory users and healthcare professionals who operate the recalled flow cytometers, particularly those working with HIV patients or immunocompromised individuals. The risk is low for most users but could impact critical medical decisions if the false counts are not corrected.
Check if your BD FACSLyric Flow Cytometer has the serial numbers listed: R651164000007 through R651164000036. The recall applies only when using BD Trucount Tubes.
Verify if your BD FACSLyric Flow Cytometer has a serial number starting with R651164000007 to R651164000036.
Do not use the recalled flow cytometer with BD Trucount Tubes until a confirmed fix is implemented.
The flow cytometer may produce excessive electronic abort counts when used with specific BD Trucount Tubes, leading to falsely high cell counts that could affect medical decisions.
Check your cytometer's serial number against the list provided. If it matches, stop using it with Trucount Tubes until a fix is confirmed.
Yes, but only with non-Trucount tubes. The recall specifically addresses issues when using 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-0070-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0070-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
