Recall Z-0304-06 ยท GGW Test, Time, Partial Thromboplastin
Dade Behring , Inc.
Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
| Date | Dec 23, 2005 (initiated Sep 23, 2005) |
| Status | Terminated |
| Reason | prolonged aPTT results |
| Root cause | Other |
| Action | The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product. |
| Quantity | 4176 packs |
| Distribution | The products were shipped to medical facilities and/or laboratories nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811589 | ACTIN FS ACTIVATED PTT REAGENT American Dade, Jul 16, 1981 |