Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
FDA device recall Z-1040-05 · posted 2005-07-22 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- positive control shows weak agglutination reaction
- Action taken
- The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 364 kits
- Distribution
- The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore,
- Date initiated
- 2005-06-21
- Date posted
- 2005-07-22
- Date terminated
- 2006-05-01
- 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 |
|---|---|---|
| DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET (K872360) | American Dade | 1987-07-06 |