CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
FDA device recall Z-0737-2007 · posted 2007-04-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- Action taken
- All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- 10
- Distribution
- Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
- Date initiated
- 2007-02-28
- Date posted
- 2007-04-11
- Date terminated
- 2007-06-13
- 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 S SYSTEM, MODEL 2138280 (K994349) | Roche Diagnostics Corp. | 2000-09-06 |
| COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING (K974569) | Boehringer Mannheim Corp. | 1998-01-09 |
| COAGUCHEK PST SYSTEM (K962571) | Boehringer Mannheim Corp. | 1997-04-22 |
| BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (K930454) | Boehringer Mannheim Corp. | 1993-08-05 |