Recall Z-0099-06 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
Roche CoaguChek System Controls; Catalog number 7745, Part numbers 054207608 and 04393201001.
| Date | Oct 28, 2005 (initiated Mar 28, 2005) |
| Status | Terminated |
| Reason | Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions. |
| Quantity | unknown. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930454 | BOEHRINGER MANNHEIM COAGUCHEK SYSTEM Boehringer Mannheim Corp., Aug 5, 1993 |
| K942884 | COAGUCHEK SYSTEM Boehringer Mannheim Corp., May 11, 1995 |
| K952625 | COAGUCHEK SYSTEM Boehringer Mannheim Corp., Nov 21, 1995 |
| K974569 | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING Boehringer Mannheim Corp., Jan 9, 1998 |