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Terminated

Tecan clinical workstation; 10-410 Tecan Genesis 150 back end, Roche catalog number 03585352001.

FDA Recall Z-0999-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJQW
Date Initiated2004-05-05
Date Terminated2007-07-24
Product Quantity11

Reason for Recall

Tecan software has the potential to match the patient with a different patient's test results.

Firm Action

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

Root Cause

Other

Distribution Pattern

Nationwide. California, Connecticut, Georgia, Illinois, Maryland, Massachusetts, Michigan, New Jersey, 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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