Professional international normalized ratio test strips manufactured by Alere are being recalled because of reports of "inaccurately low" results, including several cases of bleeding-related fatalities.
The recall applies to the "Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)," according to a company statement posted on the Food and Drug Administration’s website. The company says there have been complaints of patients with an INR in the therapeutic or near-therapeutic range with the test strip, but whose INR was significantly higher, falling outside the therapeutic range, when tested by a central laboratory.
Alere has received nine serious adverse event reports for the test strips, which included three fatal cases of bleeding. In the nine cases, the results with the Alere INRatio2 PT/INR Professional Test Strips were 3.1-12.2 INR units lower than the laboratory plasma INR test results – a significant difference, according to the statement.
"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 statement said. The company is advising customers about the problem and to immediately stop using these products "and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer."
The company is also requesting that customers send unused product back to the company.
The recall does not apply to Alere INRatio PT/INR Test Strips (PN 100071), used by patients at home. The recall was voluntary, initiated by Alere.
Adverse events or quality issues associated with this product should be reported to the FDA at www.fda.gov/medwatch or 800-332-1088. Questions about the recall and how to get replacement products should be directed to Alere at 844-292-5373; information is also available at www.inr-care.com/.