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Alere Recalls Blood Clot Test Strips

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Jarod Cassidy3 years ago

Alere Inc has initiated a voluntary recall for certain blood clot test strips after determining that false readings have resulted in at least three deaths and nine reports of severe adverse events.

About the Blood Clot Test Strip Recall

The Alere blood clot test strips allow patients to monitor how long it takes for their blood to clot. This means that patients prescribed anticoagulants or blood thinners, such as warafin, are able to test their PT/INR levels from home.

However, the strips recalled by Alere have been giving test results significantly lower than laboratory INR tests, which can result in patients taking the wrong dosage of anticoagulant medications. This could cause them to bleed more easily and in some cases, bleeding may not stop as quickly as normal.

According to Medical Daily, Alere has not yet determined what is causing the test strips to give false readings, but has acknowledged that results from the strips were between 3.1 and 12.2 INR units lower than official laboratory results.

So far, Alere has linked the defective strips to three deaths and nine serious adverse events.

Details of the Recalled Strips

  • According to a press release picked up by the Wall Street Journal, the recall affects the Alere INRatio2 PT/INR Professional Test Strips(PN 99008G2).
  • Alere will transition customers from the INRatio2 PT/INR Professional Test Strip to the Alere INRatio PR/INR Test Strip (PN 100139).
  • Consumers are urged to discontinue testing with the affected test strips immediately.


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