Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
This recall has been terminated (originally issued August 7, 2003).
- Company
- Misys Healthcare Systems
- Recall Initiated
- June 23, 2003
- Posted
- August 7, 2003
- Terminated
- April 23, 2004
- Recall Number
- Z-1093-03
- Quantity
- 157
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
Reason for Recall
Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
Distribution
Nationwide and to United Kingdom, Ireland, Canada, Denmark, Saudi Arabia, United Arab Emirates.
Lot / Code Info
Versions 5.3 up to 5.3.2.
Root Cause
Other
Action Taken
Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.
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