BD Biosciences recalls FACS Sample Prep Assistant II/III upgrades for potential probe wear causing sample clogs. Affected units may need replacement to prevent inaccurate cell counts.
The recalling firm confirmed that 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 upgrades for the BD FACSCanto system. The recall is due to probes wearing out prematurely, which can cause sample clogs and inaccurate cell counts.
The probes in these upgrades wear out before reaching the 2500 piercing guideline. When worn, rubber cap particles can clog the probe, leading to blocked or inadequate sample dispense and inaccurate cell counts.
Users of the BD FACSCanto system with FACS Sample Prep Assistant II or III upgrades are affected. Those performing lymphocyte cell counts in labs are most at risk.
Check for the BD FACS Sample Prep Assistant II or III upgrade with the product code K050191. These are used with the BD FACSCanto system for lymphocyte cell counts.
Inspect the probe for signs of wear, such as reduced piercing capability or clogs.
The probes may wear out prematurely, causing rubber cap particles to clog the probe and lead to inaccurate cell counts.
The official recall notice does not specify a remedy, so check with BD Biosciences for guidance.
Worn probes can cause blocked or inadequate sample dispense, leading to inaccurate lymphocyte 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-2357-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-2357-2020 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.
