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Terminated

Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.

FDA Recall Z-0238-04 · Posted 2004-07-20

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-07-21
Date Terminated2004-11-15
Product Quantity125

Reason for Recall

Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.

Firm Action

A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.

Root Cause

Other

Distribution Pattern

Nationwide, Canada, Saudi Arabia, United Kingdom.

Official Source

View FDA Recall →

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

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