Recall Z-0628-03 ยท GJS Test, Time, Prothrombin
Biomerieux, Inc.
BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
| Date | Mar 6, 2003 (initiated Dec 23, 2002) |
| Status | Terminated |
| Reason | Vial to vial variability which can result in prolonged clot times. |
| Root cause | Other |
| Action | Consignees were notified by letter via regular mail on December 23, 2002. They were advised to cease using the product, pull affected lot numbers, destroy the material and contact bioMerieux for replacement. Expanded recall 3/18/2003, consignees were notified by letter on March 19th , and March 31, 2003. Consignees were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement. |
| Quantity | 4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,2 |
| Distribution | CA, CO, FL, GA, IA, IN, MN, NC, NJ, TN, WI. Australia, Brazil, Buenos Aires, Canada, Colombia, Hong Kong, Japan, Korea, Mexico, Netherlands, Thailand and the United Kingdom. There were no government accounts involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882214 | SIMPLASTIN EXCEL S Organon Teknika Corp., Jul 1, 1988 |