Company: Roche Diagnostics Corp
Date of Enforcement Report: 10/16/02
Class: II
PRODUCT
Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3.
REASON
Possibile incorrect breast cancer marker results.
CODE
Serial numbers 1058-11, 1164-70 and 0806-10.
(All analyzers with software version 06-01.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8, 2002.
Manufacturer: Hitachi Ltd., Instrument Division, Ibaraki-ken, Japan. Firm initiated recall ongoing.
VOLUME OF PRODUCT IN COMMERCE
3.
DISTRIBUTION
IL and WV.
