Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
FDA device recall Z-0099-06 · posted 2005-10-28 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Action taken
- Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- GJS
- Quantity affected
- unknown.
- Distribution
- Nationwide.
- Date initiated
- 2005-03-28
- Date posted
- 2005-10-28
- Date terminated
- 2006-04-06
- 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 |
| COAGUCHEK SYSTEM (K952625) | Boehringer Mannheim Corp. | 1995-11-21 |
| COAGUCHEK SYSTEM (K942884) | Boehringer Mannheim Corp. | 1995-05-11 |
| BOEHRINGER MANNHEIM COAGUCHEK SYSTEM (K930454) | Boehringer Mannheim Corp. | 1993-08-05 |