Recall Z-0007-05 ยท GJA Test, Thrombin Time
Dade Behring , Inc.
BC Thrombin Reagent . Thrombin Time Test
| Date | Oct 5, 2004 (initiated Jul 21, 2004) |
| Status | Terminated |
| Reason | The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin |
| Root cause | Other |
| Action | The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product. |
| Quantity | 3942 kits |
| Distribution | The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970645 | BC THROMBIN REAGENT Behring Diagnostics, Inc., May 19, 1997 |