STOCKHOLM, Sweden, May 23, 2005 (PRIMEZONE) -- Getinge wishes to correct the information contained in its May 9th, 2005 Press Release. In that Press Release the company mistakenly, through miscommunications with the FDA, reported that the FDA had lifted its temporary ban on the importation to the US of Extended Care products manufactured at the Gloucester facility.
Upon further consultation with the FDA, Getinge learned that although the FDA determined that all of the measures taken by Extended Care appeared satisfactory, a successful follow-up inspection of the Gloucester facility and lifting of the import alert will be necessary before Extended Care will be permitted to resume deliveries into the US from the Gloucester facility.
The FDA has scheduled the inspection to take place starting July 25, 2005.
As previously communicated, the negative result effect from the loss of revenue as a consequence of the ban, is expected to be below SEK 15 million.
GETINGE is a leading provider of equipment and systems to customers within health care, extended care and pharmaceutical industries/laboratories. Equipment, services and technologies for infection control, operating theatres, patient hygiene, patient handling and wound care are supplied to customers throughout the world. The Getinge Group has annual sales of SEK 11 billion and 6,800 employees.
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