Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-2357-2020

Z-2357-2020 Class II Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

FDA device recall Z-2357-2020 was initiated by Becton, Dickinson and Company, BD Biosciences on July 8, 2019 and is designated Class II. Reason for recall: 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 th… The recall status is terminated (terminated January 31, 2023). Affected quantity: 51 units.

Recall Details

Product Type: Devices
Report Date: June 17, 2020
Initiation Date: July 8, 2019
Termination Date: January 31, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 51 units

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, CO,CT, GA, IL, MA, MI, MD, NC, NH,NJ, NY, OH, PA, TN, TX, VA, and VT. The countries of Australia, Botswana, Brazil, Canada, Chile, China, Colombia, Costa Rica, Europe, Hong Kong, India, Italy, Jamaica, Japan, Kazakhstan, Malaysia, Martinique, Mexico, New Zealand, Nicaragua, Peru, Puerto Rico (US), Romania, Russia, Singapore, South Africa, South Korea, Swaziland, Switzerland, Turkey, US, Vietnam.

Code Information

Catalog (Ref) No. 650686

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