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U.S. Department of Health and Human Services

Safety

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Misys Healthcare Systems laboratory information system software

Audience: Clinical laboratory administrator and risk managers

December 18, 2003: The FDA Center for Devices and Radiological Health posted a Class I recall notice for Misys Healthcare Systems laboratory information system software, used to manage patient specimens in the laboratory for the diagnosis and treatment of a patient. Version 5.3 of the software has demonstrated a defect that could result when the information system uses 3 specific functions together, i.e. Rapid Order, Calculations, and Autofiling. Use of the defective laboratory information system software could result in the release of laboratory test reports without quality assurance validation and without abnormal results flags for critical values and abnormal results.

October 22, 2003 (NOTE: The following paragraph is outdated and incorrect, and has been replaced by the notice above) The FDA Center for Devices and Radiological Health posted a Class I recall notice for Misys Healthcare Systems laboratory information system software, used to manage patient specimens in the laboratory for the diagnosis and treatment of a patient. Versions 5.2, 5.23, and 5.3 of the software have demonstrated a defect that could result in quality assurance information not being included in the patient report. Use of the defective laboratory information system software could allow the release of potentially life-threatening results directly to patients without quality assurance validation.

[Corrected December 18, 2003 - Recall Notice - FDA]