Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
FDA device recall Z-0538-05 · posted 2005-02-15 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- decrease in product stability after reconstitution and reduced stability on board certain instrument systems
- Action taken
- The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
- Root cause
- Other
- Status
- Terminated
- Product code
- DAP
- Quantity affected
- 25381 units
- Distribution
- The product was shipped nationwide to medical facilities.
- Date initiated
- 2004-12-03
- Date posted
- 2005-02-15
- Date terminated
- 2005-10-18
- Location
- Newark, DE
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED D-DIMER ASSAY (K041438) | Dade Behring, Inc. | 2004-08-11 |