Company: Roche Diagnostics, Corp
Date of Enforcement Report: 7/30/03
Class: II
PRODUCT
MagNA Pure LC Instrument; Catalog number 2236931. Recall # Z-1001-03.
REASON
Potential for false negative patient results with software version
3.0.
CODE
All units with software version 3.0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated May 27, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17.
DISTRIBUTION
Nationwide.