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Terminated

Misys Laboratory System Versions 5.2, 5.23 and 5.3

FDA Recall Z-0614-03 · Posted 2003-03-06

Recall StatusTerminated
Product CodeJQP
Date Initiated2003-01-31
Date Terminated2004-05-07
Product Quantity542

Reason for Recall

Software anomaly. Rejecting the selected Autofiling status may result in the change being accepted rather than rejected.

Firm Action

Firm sent notice by FAX on 1/31/2003. A workaround provided should prevent the problem until a software fix is made available. Clients can expect a notice when this is made available.

Root Cause

Other

Distribution Pattern

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