Recall Z-2356-2020 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Becton, Dickinson and Company, BD Biosciences
BD FACS Sample Prep Assistant (SPA) II - 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.
| Date | Jul 8, 2019 |
| Status | Terminated |
| Reason | The recalling firm confirmed that BD FACS Sample Prep Assistant (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. |
| Root 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 r |
| Quantity | 95 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, Ka |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050191 | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE Becton, Dickinson & CO, Feb 22, 2005 |