Read the 2003 MedWatch safety summary, including a link to the FDA/CDRH
recall notice, at:

http://www.fda.gov/medwatch/SAFETY/2003/safety03.htm#misys


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.