Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
FDA device recall Z-0773-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- cloudy appearance or precipitate
- Action taken
- The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.
- Root cause
- Other
- Status
- Terminated
- Product code
- GFO
- Quantity affected
- 77886 vials
- Distribution
- The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
- Date initiated
- 2004-03-01
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-19
- 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 |
|---|---|---|
| PATHROMTIN SL (K955450) | Behring Diagnostics, Inc. | 1996-04-19 |