Recall Z-0165-2009 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Roche Diagnostics Corp.
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
| Date | Oct 22, 2008 (initiated Jun 24, 2008) |
| Status | Terminated |
| Reason | A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly. |
| Root cause | Other |
| Action | The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround. |
| Distribution | Nationwide Distribution --- including states of Florida, New Jersey and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961481 | ELECSYS 2010 ANALYZER Boehringer Mannheim Corp., Jun 14, 1996 |