Cl Il Roche/Hitachi Modular Analytics System

Company: Roche Diagnostics Corp/Hitachi Ltd
Date of Enforcement Report 8/20/2008
Class:ll

PRODUCT
a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical
chemistry analyzer; Catalog number 04998618001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Z-0866-2008;
b) 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; Z-0867-2008;
c) Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay
analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative
and quantitative in vitro determinations using a wide variety of tests; Recall # Z-0868-
2008;
d) Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical
chemistry analyzer; Catalog number 03284522001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Recall # Z-0869-
2008;
e) Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay
analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in
vitro determinations using a wide variety of tests; Recall # Z-0870-2008

REASON
Possible mismatch between patient and result.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 21, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
11 units

DISTRIBUTION
Nationwide

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