Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
This recall has been terminated (originally issued January 10, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- December 15, 2003
- Posted
- January 10, 2004
- Terminated
- August 2, 2004
- Recall Number
- Z-0328-04
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
Distribution
United States.
Lot / Code Info
All units with software version 5.61 or below.
Root Cause
Other
Action Taken
Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
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