Company:Roche Diagnostics Corp.
Date of Enforcement Report 4/15/2009
Class:ll

PRODUCT
a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; 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, Recall # Z-1065-2009;

b) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module; GMMI No. 04998669001. 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, Recall # Z-1066-2009;

c) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module; GMMI No. 03284522001. 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, Recall # Z-1067-2009;

d) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module; GMMI No. 03284549001. 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, Recall # Z-1068-2009

REASON
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.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis , IN , by letter dated November 12, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki , Japan . Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
22 modules

DISTRIBUTION
Nationwide