Recall Z-1040-05 ยท GHH Fibrin Split Products
Dade Behring , Inc.
Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
| Date | Jul 22, 2005 (initiated Jun 21, 2005) |
| Status | Terminated |
| Reason | positive control shows weak agglutination reaction |
| Root cause | Other |
| Action | The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory. |
| Quantity | 364 kits |
| Distribution | The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET American Dade, Jul 6, 1987 |