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Urgent Recall Issued for Warfarin INR Test Strips

Jun 10, 2014

Alere Inc. issued a voluntary urgent recall of its INRatio2 PT/INR Professional Test Strips following reports of nine serious adverse events; three of these were bleeding injuries associated with patient deaths. The strips are used by healthcare professionals in patients who take the blood thinner warfarin to measure how long it takes the blood to clot. According to a U.S. Food and Drug Administration (FDA) Safety Alert, the strips are being recalled because local laboratory plasma INR test results were significantly different from the test strips in the adverse event reports; therefore, the strips “may report an inaccurately low INR result”.

The FDA classified the recall as Class I, the agency’s most serious recall status. A Class I recall means that the product can cause serious injury or death. The agency said that healthcare professionals should stop using the strips immediately and utilize other means to conduct PT/INR testing. Alternative methods can include plasma-based laboratory INR test, a different Alere product, or an alternative point-of-care monitoring system from a different manufacturer.

Alere stated in a press release that it does not know what might cause the inaccurate test results.  “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 company stated. Alere also said that customers who use the INRatio2 PT/INR Professional Test Strip will be transitioned to the Alere INRatio PT/INR Test Strip (PN 100139). The Alere INRatio PT/INR Test Strip (PN 100071), which is used by patients to self-monitor at home, is not affected by the recall.

Customers should return unused strips to the company, Alere said. Any problems should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail or by fax.

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