Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
This recall has been terminated (originally issued August 7, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- June 16, 2003
- Posted
- August 7, 2003
- Terminated
- April 23, 2004
- Recall Number
- Z-1090-03
- Quantity
- 315
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
Distribution
Nationwide and to UK, Ireland, Canada, Bermuda, Saudi Arabia.
Lot / Code Info
Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
Root Cause
Other
Action Taken
The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.
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