FDA Device

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.

Hazard

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

What You Should Do

Remedy

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

Products

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.
Brand
Roche Diagnostics Corp.
UPC
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768 .

Units Affected

8