FDA Statement Relating To Misys Healthcare
On Friday, 10th October, a notice was placed on the US Food and Drug
Administration's (FDA) website, relating to the recall of defective laboratory
software by Misys Healthcare Systems. We are providing the following
information to explain the facts behind this announcement.
We became aware of a defect in certain releases of our laboratory system - Misys
Laboratory - during July and immediately notified the FDA. Thereafter, acting
in strict adherence with FDA procedures, we notified all of the customers who
had installed the relevant software, provided them with an immediate means of
avoiding the problem (a 'work around' solution) and made a software fix (a '
patch') available. This fix will be automatically included in the next release
of the software.
Misys Healthcare is a leading vendor of systems used by clinical professionals
and caregivers. As such, our first concern is always for the patient, and our
business is managed to ensure that we give the quality of patient care our top
priority at all times. In this instance we acted quickly and effectively to put
those principles into practice. We communicated quickly with both the FDA and
with our customers, and we gave them the appropriate means to fix the problem.
Dealing with problems of this kind quickly and professionally is an essential
part of what we do.
Although this problem was given the highest operational priority from the
outset, our assessment was and remains that its financial impact will not be
material and that the impact on our business will be minimal.
Misys Healthcare Systems, a division of Misys plc, is among the top five healthcare IT companies in the United States. The company designs, develops, and supports a comprehensive suite of clinical information products for healthcare enterprises and currently serves over 85,000 physicians, 1,200 hospitals, 600 home care providers and hundreds of commercial laboratories, clinics, managed services and other related organizations.
Contacts
Howard Evans - Finance Director, Misys plc
Tel: 01386 871 373
Andrew Farmer - Head of Investor Relations, Misys plc
Tel: 020 7368 2307
About Misys plcMisys plc, the global software products and solutions company, serves customers in the international banking and securities, US healthcare, and UK retail financial services sectors. The group partners with its customers to deliver outstanding IT solutions to essential industries. For the year ended May 31, 2002, Misys reported revenues in excess of $1.5 billion. Misys employs more than 6,500 people internationally.
