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Terminated

Misys Laboratory System Version 5.3

FDA Recall Z-0646-03 · Posted 2003-03-13

Recalling FirmMisys Healthcare Systems
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-02-06
Date Terminated2004-05-07
Product Quantity465

Reason for Recall

Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.

Firm Action

Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003

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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