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Terminated

Misys Laboratory System versions 5.2, 5.23 and 5.3

FDA Recall Z-0626-03 · Posted 2003-03-06

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-01-31
Date Terminated2004-07-14
Product Quantity542

Reason for Recall

Software anomaly. Patient results may be filed in the incorrect patient file

Firm Action

Notice of the correction was made by Fax on 1/31/2003. The notice indicated a procedural workaround to prevent the occurance of the defect. Corrections will be made to the software at only affected sites. These have been instructed to contact Applications Interface to schedule correction of the interface.

Root Cause

Other

Distribution Pattern

Nationwide and to United Kingdom, Ireland, Belgium, Canada, Denmark, 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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