Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2356-2020 — BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human

U.S. FDA — Device Enforcement · United States · 2019-07-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2356-2020
Date of alert: 2019-07-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Becton, Dickinson and Company, BD Biosciences
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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