Recall Z-0538-05 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Dade Behring , Inc.
Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
| Date | Feb 15, 2005 (initiated Dec 3, 2004) |
| Status | Terminated |
| Reason | decrease in product stability after reconstitution and reduced stability on board certain instrument systems |
| Root cause | Other |
| Action | The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved. |
| Quantity | 25381 units |
| Distribution | The product was shipped nationwide to medical facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041438 | ADVANCED D-DIMER ASSAY Dade Behring, Inc., Aug 11, 2004 |