RecallDepth

Mysis Laboratory version 6.1

This recall has been terminated (originally issued June 28, 2005).

Company
Misys Healthcare Systems
Recall Initiated
May 10, 2005
Posted
June 28, 2005
Terminated
August 30, 2005
Recall Number
Z-0939-05
Quantity
21
Firm Location
Tucson, AZ
Official Source
View on FDA website ↗

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.

Distribution

Nationwide and United Kingdom and Denmark

Lot / Code Info

Version 6.1

Root Cause

Other

Action Taken

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.

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