BIOMERIEUX, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent, bioMerieux, Inc., Durham, NC 27704
FDA device recall Z-0628-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Biomerieux, Inc.
- Reason for recall
- Vial to vial variability which can result in prolonged clot times.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 4276 kits of lot #161553, 4275 kits of lot #161580, 4279 kits of lot #161581 and 4300 kits of lot 161661. Additional 2,280 kits of lot 161662.
- 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 a
- Date initiated
- 2002-12-23
- Date posted
- 2003-03-06
- Date terminated
- 2004-01-21
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMPLASTIN EXCEL S (K882214) | Organon Teknika Corp. | 1988-07-01 |