Simplastin L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
FDA device recall Z-1238-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- Complaints of prolonged clot times.
- Action taken
- Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 689 units
- Distribution
- The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
- Date initiated
- 2003-07-31
- Date posted
- 2003-10-15
- Date terminated
- 2004-05-18
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.