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Terminated

Tecan clinical workstation; Tecan Genesis 150/8 TCW front end COBAS (FEC), Roche catalog number 0360053001.

FDA Recall Z-0997-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJQW
Date Initiated2004-03-05
Date Terminated2007-08-07
Product Quantity8

Reason for Recall

If the files are not periodically purged from the TCW computer, it may result in patient identification/sample results mismatches.

Firm Action

Roche sent each of their consignees revised Tecan database maintenance instruction via bulletin 04-042 dated 3/5/04.

Root Cause

Other

Distribution Pattern

Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, 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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