Recall Z-1940-2010 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
| Date | Jun 30, 2010 (initiated Feb 19, 2010) |
| Status | Terminated |
| Reason | Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe |
| Root cause | Nonconforming Material/Component |
| Action | The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call. |
| Quantity | 349 units |
| Distribution | Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay. |
| 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 |