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Terminated

Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.

FDA Recall Z-0996-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJQW
Date Initiated2004-03-05
Date Terminated2007-08-07
Product Quantity14

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953345GENESISTecan U.S., Inc. · 1995-11-21

Official Source

View FDA Recall →

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

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