Recall Z-0172-06 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Dade Behring , Inc.
Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
| Date | Nov 18, 2005 (initiated Jul 29, 2005) |
| Status | Terminated |
| Reason | Reports of false negative results on Sysmex Coagulation System. |
| Root cause | Other |
| Action | On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method. |
| Quantity | 2987 units |
| Distribution | The product was shipped to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041438 | ADVANCED D-DIMER ASSAY Dade Behring, Inc., Aug 11, 2004 |