An urgent product recall has been issued for PT/INR test strips manufactured by Alere.
The company says that it has voluntarily issued a recall of its INRatio®2 PT/INR Professional Test Strips (PN 99008G2).
Forbes reports that some patients who have therapeutic or near-therapeutic international normalized ratio (INR) readings have reported experiencing significantly INR readings when their results are double-checked in a laboratory.
These inaccurate results have sparked an urgent recall because it could mean that some patients are at risk for spontaneous bleeding. Three consumer deaths have been associated with bleeding.
Patients using PT/INR test strips are typically on medication such as warfarin/Coumadin or heparin injections, which are blood thinners. This type of medication is given to people who have had heart attacks, suffer irregular heartbeats, or have had heart valve surgery.
“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 said in a statement (PDF) “Alere has notified customers of the discrepant results and has advised them to immediately STOP using the Alere INRatio2 PT/INR Professional Test Strips and use an alternative method to perform PT/INR testing.”
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