Recall Z-0054-05 ยท GJA Test, Thrombin Time
bioMerieux
Fibriquik, bioMeriux, Inc., Box 15969, Durham, North Carolina 27704-0969
| Date | Oct 28, 2004 (initiated Aug 20, 2004) |
| Status | Terminated |
| Reason | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. |
| Root cause | Other |
| Action | Consignees were notified by letter on 8/20/2004. |
| Quantity | 2406 units |
| Distribution | Nationwide, Australia, Brazil, Canada, China, Japan, Laos, Philippines, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.