Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
FDA device recall Z-0098-06 · 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 PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (K030845) | Roche Diagnostics Corp. | 2003-05-22 |
| PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 (K021190) | Roche Diagnostics Corp. | 2002-10-25 |
| COAGUCHEK PST SYSTEM (K962571) | Boehringer Mannheim Corp. | 1997-04-22 |