Recall Z-1239-03 ยท GJS Test, Time, Prothrombin
bioMerieux
MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
| Date | Oct 15, 2003 (initiated Jul 31, 2003) |
| Status | Terminated |
| Reason | Complaints of prolonged clot times. |
| Root cause | Other |
| Action | Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached. |
| Quantity | 857 units |
| Distribution | The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.