BD Biosciences recalls FACS Sample Prep Assistants II/III for potential probe wear causing sample clogs in flow cytometry. Affected units may need replacement to prevent inaccurate cell counts.
The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
BD Biosciences is recalling FACS Sample Prep Assistant II and III devices because worn probes can cause sample clogs in flow cytometry. This may lead to inaccurate cell counts if the device is used without proper maintenance.
Worn probes can cause rubber cap particles to clog the sample path, leading to blocked or inadequate sample dispensing. This may result in inaccurate cell counts during flow cytometry analysis.
Users of BD FACS Sample Prep Assistant II or III devices for flow cytometry testing are most at risk. This includes laboratory technicians and researchers working with blood cell samples.
Check for the BD FACS Sample Prep Assistant II or III models. The product is used with BD FACSCanto systems and clinical software for lymphocyte subset analysis.
Inspect the probe for signs of wear, such as reduced piercing capability or clogs.
The recall occurs because probes may wear out before reaching the 2500 piercings guideline, causing sample clogs and inaccurate cell counts.
Check if you have a BD FACS Sample Prep Assistant II or III used with BD FACSCanto systems for lymphocyte subset analysis.
Inspect the probe for wear; if clogged, replace the probe to prevent inaccurate cell counts.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2356-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-2356-2020 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.
