Recall Z-1370-2015 ยท OYE Flow Cytometric Reagents And Accessories.
BD Biosciences, Systems & Reagents
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
| Date | Jun 26, 2015 (initiated Mar 6, 2015) |
| Status | Terminated |
| Reason | The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation. |
| Root cause | Mixed-up of materials/components |
| Action | BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080. |
| Quantity | 72 devices |
| Distribution | Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980858 | MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION Becton Dickinson Immunocytometry Systems, May 22, 1998 |