Misys Laboratory System, versions 5.2, 5.23 and 5.3
This recall has been terminated (originally issued July 15, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- June 10, 2003
- Posted
- July 15, 2003
- Terminated
- April 23, 2004
- Recall Number
- Z-1007-03
- Quantity
- 467
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and to Ireland, Canada, Denmark, Bermuda, UK, Saudi Arabia, United Arab Emirates.
Lot / Code Info
Versions 5.2, 5.23 and 5.3
Root Cause
Other
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.
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