Class 2 Device Recall BD FACS Sample Prep Assistant (SPA) II Upgrade

• Date Initiated by Firm: July 08, 2019
• Create Date: June 11, 2020
• Recall Status: Terminated on January 31, 2023
• Recall Number: Z-2357-2020
• Recall Event ID: 85129
• 510(K)Number: K050191
• Product Classification: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis - Product Code PER
• 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.
• Code Information: Catalog (Ref) No. 650686
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Biosciences; 2350 Qume Dr; San Jose CA 95131-1812
• For Additional Information Contact: 855-236-2772
• Manufacturer 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.
• FDA Determined Cause: Component design/selection
• Action: The recall was initiated by customer letter dated July 8th, 2019 via UPS/FEDEX and email. The following actions are to be taken: Follow the FACS Sample Prep Assistant II or III System Instructions for Use (IFU) directions for inspecting the probe daily for wear as part of the daily startup procedure. For both SPA II and III IFUs, this may be found in Chapter 5. Instructions for replacing the probe can be located in the Shutdown and Maintenance chapter of the IFU. For SPA II this may be found in Chapter 7. For SPA III this may be found in Chapter 6. The following provides additional detail regarding the probe inspection process: 1. Visually check the probe for signs of wear (the probe is no longer straight or the Teflon coating is gone). Note: the probe does not need to be removed from the system for this inspection. 2. Replace and discard the probe in accordance with the IFU if the probe shows signs of unacceptable wear. Report any adverse health consequences experienced with the use of this product . Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA-1088 (1-800-332-1088). For further assistance, contact Customer Support at 855236-2772 (prompt 2), and for customers outside the US , contact the local representative or distributor.
• Quantity in Commerce: 51 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PER and Original Applicant = BECTON DICKINSON & CO.