Company: Roche Diagnostics Corp
Date of Enforcement Report: 6/23/04
Class: I
PRODUCT
COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall # Z-1021-04.
REASON
The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.
CODE
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 5, 2004 and press release on May 7, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, CT, IL, MA, PA, TX and WI.
