Recall Z-1431-04 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche/Hitachi Modular Additional D Module DAT clinical chemistry analyzer; catalog number 04429389160.
| 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 under certain conditions. |
| 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. |
| Distribution | United States. |
| 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 |