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U.S. Department of Health and Human Services

Medical Devices

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Laboratory Information System

Class I Recall
Date Recall
Initiated:
August 12, 2003
Product:
Laboratory information system software device, version 5.3
Use:
This information system is used to manage patient specimens in the laboratory for the diagnosis and treatment of a patient.
Recalling Firm:
Misys Healthcare Systems
4801 E. Broadway Blvd.
Tucson, Arizona 85711
Reason for Recall:
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.
Public Contact:
Misys Client Advocate
1-877-239-6337 (domestic)
44 (0) 161 335 0562 (international)
FDA District:
Los Angeles
FDA Comment:
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.