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Terminated

Misys Laboratory versions 5.23 and 5.3 with Callback

FDA Recall Z-0324-03 · Posted 2002-12-05

Recall StatusTerminated
Product CodeJQP
Date Initiated2002-10-18
Date Terminated2004-12-01
Product Quantity463

Reason for Recall

Software anomally - animal ranges, when desired on reports, are defaulting to human male ranges.

Firm Action

Notice of recall was sent by fax on October 18, 2002. A software fix will be available for version 5.3 in January 2003. Users will be notified again of this new release and be urged to update from version 5.23 to version 5.3. Completion of the recall is estimated to be in March 2003.

Root Cause

Other

Distribution Pattern

Nationwide and to the United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, and United Arab Emirates,

Official Source

View FDA Recall →

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

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