Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100
FDA device recall Z-0304-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- prolonged aPTT results
- Action taken
- The recalling firm issued a letter dated 9/30/05 informing the customers of the problem and instructing them to discontinue use of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GGW
- Quantity affected
- 4176 packs
- Distribution
- The products were shipped to medical facilities and/or laboratories nationwide.
- Date initiated
- 2005-09-23
- Date posted
- 2005-12-23
- Date terminated
- 2006-05-11
- 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 |
|---|---|---|
| ACTIN FS ACTIVATED PTT REAGENT (K811589) | American Dade | 1981-07-16 |