Recall Z-0870-2008 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
| Date | Aug 13, 2008 (initiated Mar 21, 2008) |
| Status | Terminated |
| Reason | Possible mismatch between patient and result. |
| Root cause | Process change control |
| Action | Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software. |
| Quantity | 11 of all models |
| Distribution | Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953239 | BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER Boehringer Mannheim Corp., Sep 25, 1995 |