Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product
FDA device recall Z-0629-03 · posted 2003-03-06 · Terminated
Recall details
- Recalling firm
- Biomerieux, Inc.
- Reason for recall
- Product is being recalled due to vial to vial variability of clotting time results.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 62,435 units, Expanded Lot #161659, 3525 boxes; 161660, 1489 boxes; 161711, 3990 boxes
- Distribution
- Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
- Date initiated
- 2003-02-04
- Date posted
- 2003-03-06
- Date terminated
- 2004-01-21
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMPLASTIN EXCEL (K864283) | Organon Teknika Corp. | 1986-12-04 |