BC Thrombin Reagent . Thrombin Time Test
FDA device recall Z-0007-05 · posted 2004-10-05 · Terminated
Recall details
- Recalling firm
- Dade Behring , Inc.
- Reason for recall
- The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
- Action taken
- The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJA
- Quantity affected
- 3942 kits
- Distribution
- The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Aust
- Date initiated
- 2004-07-21
- Date posted
- 2004-10-05
- Date terminated
- 2004-12-15
- 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 |
|---|---|---|
| BC THROMBIN REAGENT (K970645) | Behring Diagnostics, Inc. | 1997-05-19 |