CoaguChek PT test strips, sold in 12 pack.
FDA device recall Z-0720-03 · posted 2003-04-10 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Discrepancy between INR and the % Quick displayed on the meter.
- Action taken
- Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
- Root cause
- Other
- Status
- Terminated
- Product code
- JPA
- Quantity affected
- 11412 containers
- Distribution
- Germany
- Date initiated
- 2003-02-20
- Date posted
- 2003-04-10
- Date terminated
- 2003-11-10
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569) | Boehringer Mannheim Corp. | 1998-01-09 |