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Terminated

Mysis Laboratory version 6.1

FDA Recall Z-0939-05 · Posted 2005-06-28

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2005-05-10
Date Terminated2005-08-30
Product Quantity21

Reason for Recall

When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.

Firm Action

Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.

Root Cause

Other

Distribution Pattern

Nationwide and United Kingdom and Denmark

Official Source

View FDA Recall →

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

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