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Terminated

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.

FDA Recall Z-1021-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2004-05-05
Date Terminated2007-07-24
Product Quantity8

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

California, Connecticut, Illinois, Massachusetts Pennsylvania, Texas and Wisconsin.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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