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Terminated

Misys Laboratory with Lab Access Results application for versions 5.3 and later.

FDA Recall Z-0938-05 · Posted 2005-06-28

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2005-05-13
Date Terminated2006-02-10
Product Quantity258

Reason for Recall

Software anomaly may rarely allow modification of previously reported specimen results.

Firm Action

Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.

Root Cause

Other

Distribution Pattern

Nationwide and United Kingdom, Ireland, Denmark, Canada, 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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