Recall Issued for Alere INRatio2 PT/INR Professional Test Strips

Results disagree with confirmed PT/INR reference test results performed by central laboratory


May 30, 2014

May 30, 2014 — Alere announced a class I recall of its INRatio2 PT/INR professional test strips, part of the Alere lNRatio2 PT/INR monitoring system (professional use) which also consists of the INRatio2 monitor. This recall is expected to cause a shortage of test strips for the Alere INRatio2 professional PT/INR testing. Alere will transition customers from the current Alere INRatio2 PT/INR professional test strip to the Alere INRatio PT/INR test strip, which is not affected by the recall and is used by patient self-testers for home INR monitoring but has also been validated for professional use.

The affected test strips were manufactured from Aug. 22, 2013, through April 2, 2014, and distributed from Aug. 26, 2013, through April 2, 2014.

The Alere lNRatio2 PT/INR monitoring system (professional use) is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin on clotting time (prothrombin time). The system is intended for use outside of the body (in vitro diagnostic use) and not intended to be used for screening purposes. It is also not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

Initiated in April, the recall is due to complaints of patients who had a therapeutic or near-therapeutic INR result with the Alere INRatio2 PT/INR professional test strip but a significantly higher INR result (outside of therapeutic range) when retesting was performed by a central laboratory because of deterioration in the patient’s clinical condition. Use of this affected product may cause serious adverse health consequences, including death. At the time of writing Alere San Diego received nine reports of malfunctions; six injuries and three deaths caused by bleeding.

On April 17, 2014, Alere sent an Urgent Medical Device Recall letter to all affected customers by fax, email or direct mail. The letter identified the product, problem and the actions to be taken. Customers were requested to complete and sign a Reply Form that was included with the letter. Alere requested the completed form be sent by fax or by email.

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