Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
This recall has been terminated (originally issued March 6, 2003).
- Company
- Biomerieux, Inc.
- Recall Initiated
- February 4, 2003
- Posted
- March 6, 2003
- Terminated
- January 21, 2004
- Recall Number
- Z-0629-03
- Quantity
- 62,435 units, Expanded Lot #161659, 3525 boxes; 161660, 1489 boxes; 161711, 3990 boxes
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product is being recalled due to vial to vial variability of clotting time results.
Distribution
Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
Lot / Code Info
Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
Root Cause
Other
Action Taken
Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and 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.