Recall Z-1007-2010 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.
| Date | Apr 16, 2010 (initiated Jan 29, 2009) |
| Status | Terminated |
| Reason | The product is mislabeled, in that, zero/low controls were mislabeled as medium/high, and the medium/high controls were labeled zero/low. |
| Root cause | Package design/selection |
| Action | On 1/29/09, the firm initiated the recall and its notification was via Important Product Information letters identifying the affected product and explaining the reason for the recall. Customers who experienced error codes with the affected product were to contact their local BD Biosciences representative or distributor to receive replacement BD FACSCount controls. |
| Quantity | 17 units |
| Distribution | Nationwide Distribution -- Including states of WA, MO, NV, CA, NY, PA, AL, and OR. |
| FDA record | Open on fda.gov |