Alere to Voluntarily Pull Blood-Monitoring Devices
July 11 2016 - 7:04PM
Dow Jones News
By Maria Armental
Alere Inc. will voluntarily recall blood-monitoring devices that
produced some erroneous readings of how quickly patients' blood
clots when they are taking anticoagulant medicines.
The Waltham, Mass., company had found that in certain cases the
blood-monitoring systems in question, the INRatio and INRatio 2,
provided blood clotting time "that is clinically significantly
lower than" tests done at laboratories.
Alere, which added the hand-held monitoring systems as part of
its 2007 HemoSense acquisition, said it was working with health
regulators on the timing of the recall.
The Food and Drug Administration is looking into the matter
after linking erroneous readings on such devices to deaths and
serious injuries.
The company, which has received a buyout offer from Abbott
Laboratories, is under federal investigation for business practices
in Africa, Asia and Latin America. Alere's troubles have raised
concerns over whether the merger will go through. In April, Alere's
board rejected Abbott's proposal to end the merger agreement.
Shares, which set a 52-week-low in January at $31.96, were down
2% to $39.01 in after-hours trading.
Write to Maria Armental at maria.armental@wsj.com
(END) Dow Jones Newswires
July 11, 2016 18:49 ET (22:49 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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