medical Class II Updated 2020-06-17

Becton, Dickinson and Company, BD Biosciences recalls BD FACS Sample Prep Assistant (SPA) III - Product Usage: Pre

Recalled Product

BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II and BD FACSCalibur flow cytometry systems. Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems


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. 647205
View official government recall

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