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Terminated

Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module

FDA Recall Z-1090-03 · Posted 2003-08-07

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-06-16
Date Terminated2004-04-23
Product Quantity315

Reason for Recall

Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.

Firm Action

The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.

Root Cause

Other

Distribution Pattern

Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.

Official Source

View FDA Recall →

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

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