Company: Roche Diagnostics Corp
Date of Enforcement Report: 9/15/04
Class: II
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-1371-04.
REASON
A hardware/software problem will result in low elution volumes and bias sample results for various protocols.
CODE
All units using software version 3.03.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letter dated August 6, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
192.
DISTRIBUTION
Nationwide.