Company: Roche Diagnostics Corp
Date of Enforcement Report 3/12/2008
Class:ll
PRODUCT
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Recall # Z-0576-2008
REASON
Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone and follow-up letter dated December 4, 2007.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NB