Recall Z-1428-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
| Date | Sep 2, 2004 (initiated Aug 6, 2004) |
| Status | Terminated |
| Reason | A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time. |
| Root cause | Other |
| Action | Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it. |
| Quantity | 254 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901003 | BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER Boehringer Mannheim Corp., Apr 16, 1990 |