Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyzer; Catalog number 04998669001. Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
This recall has been terminated (originally issued August 13, 2008).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- March 21, 2008
- Posted
- August 13, 2008
- Terminated
- November 18, 2009
- Recall Number
- Z-0867-2008
- Quantity
- 11 of all models
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Possible mismatch between patient and result.
Distribution
Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
Lot / Code Info
All units with software version 08-02.
Root Cause
Process change control
Action Taken
Consignees were notified via Urgent Medical Device Correction letter dated 3/21/08, which instructed them to not manually order QC test selections while the system is in operation mode and that they can only manually order QC when the system is in Stand-by mode. Consignees are instructed to consult with their physicians or pathologist to determine specific clinical implications for their patients. The firm states that this issue will be resolved in the next version of software.