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
- Recall Initiated
- July 8, 2019
- Terminated
- January 31, 2023
- Recall Number
- Z-2358-2020
- Quantity
- 467 units
- Firm Location
- San Jose, CA
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
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.
Lot / Code Info
Catalog (Ref) No. 647205
Root Cause
Component design/selection
Action Taken
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.