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Terminated

Misys Laboratory System Version 5.3

FDA Recall Z-0670-03 · Posted 2003-03-21

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-02-19
Date Terminated2004-06-02
Product Quantity464

Reason for Recall

Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry

Firm Action

Notification was made by FAX to customers. A procedureal work around was provided also. The firm will announce the availability of a software fix in the future.

Root Cause

Other

Distribution Pattern

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