Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704
FDA device recall Z-0843-05 · posted 2005-05-18 · Terminated
Recall details
- Recalling firm
- BIOMERIEUX, INC.
- Reason for recall
- 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.
- Action taken
- Consignees were notified by letter on/about March 7, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 19748 kits
- Distribution
- Nationwide, Canada, Colombia, India, Philippines, Spain, Thailand
- Date initiated
- 2005-03-07
- Date posted
- 2005-05-18
- Date terminated
- 2006-10-16
- 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 |
|---|---|---|
| MDA SIMPLASTIN HTF (K974566) | Organon Teknika Corp. | 1998-02-24 |