Company: Roche Diagnostics Corp
Date of Enforcement Report: 12/22/04
Class: II
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05.
REASON
Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09.
CODE
All systems using software version 3.09.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated November 5, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
65.
DISTRIBUTION
Nationwide.
