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Terminated

Misys Laboratory System, versions 5.2, 5.23 and 5.3

FDA Recall Z-1007-03 · Posted 2003-07-15

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-06-10
Date Terminated2004-04-23
Product Quantity467

Reason for Recall

Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.

Firm Action

Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.

Root Cause

Other

Distribution Pattern

Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, 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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