Company:Data Innovations, Inc.
Date of Enforcement Report:12/6/2006
Class:ll
PRODUCT
a) Roche Modular Drive (rchmdlri), analytical laboratory data interface,
Recall # Z-0223-2007;
b) Roche Cobas driver (rchcob6i), analytical laboratory data interface,
Recall # Z-0224-2007
REASON
Software of modular driver may incorrectly report patient results as Quality Control Results.
CODE
a) Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024;
b) Software version: v8.00.0001 and v7.00.0001
RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., South Burlington,VT., by letter dated October 25, 2006. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION
Nationwide and Canada
