Recall Z-0843-05 ยท GJS Test, Time, Prothrombin
BIOMERIEUX, INC.
Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
| Date | May 18, 2005 (initiated Mar 7, 2005) |
| Status | Terminated |
| Reason | The ISI labeling for Simplastin HTF on the Coag-a-Mate MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about March 7, 2005. |
| Quantity | 19748 kits |
| Distribution | Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974566 | MDA SIMPLASTIN HTF Organon Teknika Corp., Feb 24, 1998 |