medical Class II Updated 2020-06-17

Becton, Dickinson and Company, BD Biosciences recalls BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usa

Recalled Product

BD FACS Sample Prep Assistant (SPA) II Upgrade - 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 cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog (Ref) No. 650686
View official government recall

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