—#33086

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.

Affected lot / code info: All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .

Why it was recalled

The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.

Root cause (FDA determination)

Other

Action the firm took

Press release was issued 5/7/04 and recall letter dated 5/5/04 was sent to each user consignee.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.

Timeline

Recall initiated: 2004-05-05
Posted by FDA: 2004-07-20
Terminated: 2007-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33086. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.