Mysis Laboratory version 6.1
FDA device recall Z-0939-05 · posted 2005-06-28 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 21
- Distribution
- Nationwide and United Kingdom and Denmark
- Date initiated
- 2005-05-10
- Date posted
- 2005-06-28
- Date terminated
- 2005-08-30
- Location
- Tucson, AZ
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