May 6 Alere Inc said it initiated a
voluntary recall of certain blood clot test strips in the United
States following reports of nine serious adverse events that
included bleeding related to the death of three patients.
The test strip, PN 99008G2, measures how long it takes blood
to clot in patients taking blood thinner warfarin and is used
with Alere's INRatio2 PT/INR monitor.
The health diagnostics and services company said the adverse
events were due to significantly different test results between
the strip and the local laboratory plasma test.
"The root cause for this issue has not yet been determined;
therefore Alere cannot determine the patient conditions or
circumstances that may contribute to the discrepancy," the
Alere has asked customers to immediately stop using the test
The company said it has reported the complaints to the U.S.
Food and Drug Administration.
Alere shares were unchanged at $35.51 in early trade on the
Nasdaq on Tuesday.
(Reporting by Shailesh Kuber; Editing by Sriraj Kalluvila)