BD Biosciences recalls SPA III blood prep devices due to probe wear causing sample clogging. Affected users should check for worn probes before use.
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 Biosci: The SPA III blood preparation device may have probes that wear out before the 2500 piercing guideline, causing blood samples to clog. This could lead to inaccurate test results or failed analyses.
Worn probes can cause rubber cap particles to clog the probe, leading to blocked or inadequate sample dispense. This may result in inaccurate test results or failed analyses when preparing blood samples.
Users of BD FACS Sample Prep Assistant III devices for blood testing who prepare samples for flow cytometry. Those with frequent use may be at higher risk of clogged probes.
The BD FACS Sample Prep Assistant III is used for preparing human whole blood for flow cytometry systems. Check if the probe has worn out before reaching 2500 piercings as per the manufacturer's guidelines.
Inspect the probe for signs of wear before use to ensure it hasn't exceeded the 2500 piercing guideline.
Worn probes can cause rubber cap particles to clog the probe, leading to blocked or inadequate sample dispense.
The probe may have worn out before reaching the 2500 piercings guideline indicated in the manufacturer's instructions.
Check the probe condition before use; if worn, replace it to prevent sample clogging.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2358-2020 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-2358-2020 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.
