Recall Z-0100-06 ยท GJS Test, Time, Prothrombin
Roche Diagnostics Corp.
Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
| 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
| K994349 | COAGUCHEK S SYSTEM, MODEL 2138280 Roche Diagnostics Corp., Sep 6, 2000 |