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.
Hazard
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.
What You Should Do
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.
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
- Brand
- Roche Diagnostics Corp.
- UPC
- All units with software version 08-03.
Units Affected
22 systems in all