Company: Roche Diagnostics, Corp
Date of Enforcement Report: 8/6/03
Class: II
PRODUCT
MagNA Pure LC Instrument, Catalog number 2236931. Recall # Z-1044-03.
REASON
A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
CODE
All systems using software version 3.0.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letter dated June 26, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17.
DISTRIBUTION
Nationwide, and Canada.