Misys Laboratory System, versions 5.2, 5.23 and 5.3
FDA device recall Z-1007-03 · posted 2003-07-15 · Terminated
Recall details
- Recalling firm
- Misys Healthcare Systems
- Reason for recall
- Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
- Action taken
- Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 467
- Distribution
- Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, Saudi Arabia, United Arab Emirates.
- Date initiated
- 2003-06-10
- Date posted
- 2003-07-15
- Date terminated
- 2004-04-23
- Location
- Tucson, AZ
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