BD Biosciences recalls BD FACSLyric Flow Cytometers (serial numbers listed) when used with BD 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 specific models of their FACSLyric Flow Cytometers when used with Trucount Tubes. This can cause inaccurate cell counts that might lead to incorrect medical decisions for HIV patients and others with weakened immune systems.
Using the recalled flow cytometers with Trucount Tubes can cause electronic abort counts to exceed 1.0% of processed events. This leads to falsely high cell counts, which may affect critical medical decisions like starting prophylactic therapy for HIV patients or managing immune-suppressed conditions.
Laboratory users and healthcare professionals who operate the recalled flow cytometers with Trucount Tubes. Patients relying on accurate cell counts for treatment decisions are at risk of incorrect medical outcomes.
Check if your BD FACSLyric Flow Cytometer has serial numbers starting with R663029 or R659180 (as listed in the recall). The issue occurs only when using BD Trucount Tubes.
Verify your flow cytometer's serial number against the list of affected units provided in the recall notice.
Do not use the recalled flow cytometers with BD Trucount Tubes until a confirmed fix is implemented.
The flow cytometers may produce excessive electronic abort counts when used with Trucount Tubes, leading to inaccurate cell counts that could affect medical decisions.
Check your flow cytometer's serial number against the list provided in the recall. Do not use it with Trucount Tubes until the issue is resolved.
This is a technical issue that could affect medical accuracy but does not pose a direct safety risk like fire or injury. The hazard level is low risk.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0074-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0074-2020 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.
