Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.
This recall has been terminated (originally issued April 10, 2009).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- November 12, 2008
- Posted
- April 10, 2009
- Terminated
- September 22, 2009
- Recall Number
- Z-1065-2009
- Quantity
- 22 systems in all
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.
Distribution
Nationwide Distribution -- including states of California, Florida, Georgia, Hawaii, Indiana, Maryland, New York, North Carolina, Pennsylvania, and Virginia.
Lot / Code Info
All units with software version 08-03.
Root Cause
Software change control
Action Taken
Consignees were notified via an Urgent Medical Device Correction letter dated 11/12/08 and instructed to only execute "module unmasking" when the unit is in "standby" mode and to consult with their physicians at the facility to determine the clinical implications and whether any clinical intervention is needed for patients treated based upon results obtained with this software. Questions should be directed to Roche Diagnostics Technical Support at 1-800-428-2336.