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Misys Healthcare Issues Domestic and International Recall of Misys Laboratory, a Laboratory Information System Software Device

This is a revised version of FDA Press Release P03-79, issued on Oct. 10, 2003.
Corrections were made to the original version, which is now obsolete.

Misys Healthcare Systems of Tucson, Ariz., is initiating a domestic and international recall of the Misys Laboratory software versions 5.2, 5.23 and 5.3. In some instances, these particular versions of this software have demonstrated a defect that could result in quality assurance filters and flags not being included in the patient report used for the diagnosis and/or treatment of a patient.

To date no injuries have been reported in connection with this problem. FDA has been made aware of the recall and is working with the company.

The recalled products have been distributed to health care facilities throughout the world. Misys Healthcare Systems is notifying its customers and strongly advising that the health care institutions using this product request the individual code correction package B-AUT-RAPID-LAB as soon as possible.

Such requests should be made to the Misys Client Advocate at 1-877-239-6337. European clients may call 44 (0) 161 335 0562.

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