Recall Z-1446-06 ยท GKE Osmotic Fragility Testing
Becton Dickinson & Company
BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
| Date | Aug 26, 2006 (initiated Jun 1, 2005) |
| Status | Terminated |
| Reason | Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis |
| Root cause | Other |
| Action | Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005 |
| Quantity | Lot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits |
| Distribution | World wide-USA, Canada, Europe, Asia Pacific. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.