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Terminated

Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.

FDA Recall Z-1093-03 · Posted 2003-08-07

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-06-23
Date Terminated2004-04-23
Product Quantity157

Reason for Recall

Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.

Firm Action

Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.

Root Cause

Other

Distribution Pattern

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