Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos. 04998642001 and 03617505001.
This recall has been terminated (originally issued October 22, 2008).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- June 24, 2008
- Posted
- October 22, 2008
- Terminated
- October 22, 2009
- Recall Number
- Z-0165-2009
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
Distribution
Nationwide Distribution --- including states of Florida, New Jersey and North Carolina.
Lot / Code Info
All units with software version 08-02.
Root Cause
Other
Action Taken
The consignees were notified of the problem via letter dated 6/24/08 and were provided instructions for a workaround.
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