Recall Z-0316-2011 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
| Date | Nov 3, 2010 (initiated Feb 19, 2010) |
| Status | Terminated |
| Reason | Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. The piece of the lid clogging the Probe can be in the processed sample tube. It has the |
| Root cause | Device Design |
| Action | BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers |
| Quantity | 349 units |
| Distribution | Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.