Recall Z-0098-06 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
Roche CoaguChek System Controls (patient self testing); Catalog number 763, Part numbers 054200705 and 047514003.
| 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 |