|Alere INRatio2 PT/INR monitoring system--Courtesy of Alere|
In reaction to three patient deaths associated with its INRatio2 PT/INR Professional Test Strips, Alere ($ALR) initiated a voluntary Class I recall of the products.
Alere said it took action following patient complaints that the measurements of the test strips, used to measure blood clotting time in patients on warfarin, were lower than the results from lab tests.
The test strip results were between 3.1-12.2 INR units lower than the lab result, the company said in a May 7 statement, and it is concerned that the test strips may be inaccurate and underestimate the INR.
Alere said the "root cause" of the issue is not yet known. It urged customers to stop using the product and return unused test strips to the company. The release says that Alere will transition customers to the Alere INRatio PT/INR Test Strip.
The recall was initiated as a result of 9 serious adverse event reports. The three deaths involved bleeding, Alere said.
The bad news comes at a time of internal tumult. On Monday the company appointed Alere shareholder and CEO of Private Capital Management, Gregg Powers, as chairman of the board in place of CEO Ron Zwanziger. It recently announced plans to spin off its BBI Diagnostics unit, and more changes could be on the way.
On Monday it also said it is "undertaking a comprehensive review of its strategy and operations to identify opportunities to enhance shareholder value."
- read the release