Company: Roche Diagnostics Corp/Hitachi LTD
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Roche/Hitachi Modular E Module immunoassay analyzer, GMMI Nos. 04998642001 and 03617505001, Recalling Firm: Z-0165-2009
REASON
A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 24, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide