MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Ca
FDA device recall Z-1239-03 · 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
- 857 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
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