BD BioSciences recalls two blood analysis systems that may cause inaccurate blood counts due to software errors, requiring users to check specimen volumes and absolute counts.
Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
BD BioSciences is recalling two blood analysis systems that may cause inaccurate blood test results. If the software calculates blood counts incorrectly, it could lead to extra blood draws or delayed patient treatment.
The software may calculate blood counts incorrectly when using specific tube configurations. This could cause the system to report 20% higher counts in one tube than another, leading to additional blood draws or delayed patient treatment.
Healthcare professionals using BD FACSDuet Sample Preparation Systems with software version 1.4.1 may be affected. Patients receiving blood tests from these systems could face inaccurate results.
Check for model numbers 666340, 666339, 663128, or 662588 with serial numbers listed in the recall notice. These systems were sold with software version 1.4.1.
Verify the software version on your device; if it's 1.4.1, it may be affected.
Ensure specimen volumes in both tubes are within the correct range to avoid inaccurate results.
The software may calculate blood counts incorrectly when using specific tube configurations, potentially causing inaccurate results.
No serious injury is likely, but inaccurate blood results could lead to extra blood draws or delayed patient treatment.
Check your software version; if it's 1.4.1, review specimen volumes to ensure accuracy.
We’ve drafted a message you can send BD BioSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0009-2025 — BD BioSciences BD BioSciences Hello, I own a BD BioSciences that is covered by recall Z-0009-2025 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.
