Company: Roche Diagnostics Corp
Date of Enforcement Report: 10/22/03
Class: II
PRODUCT
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04.
REASON
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted.
CODE
All units with current software versions (v 06-06 and 07-01).
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter on or about May 12, 2003. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
478.
DISTRIBUTION
Nationwide.
