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Alere Settles Lawsuit Alleging it Sold Inaccurate Blood Test

NEW YORK (360Dx) – Alere has settled a lawsuit, which alleged the company misled consumers by selling them inaccurate blood test monitoring systems used in the home.

In a complaint filed with the US District Court District of Massachusetts in July, plaintiffs' lawyers said that Alere sold the systems — used to test how quickly blood clots in patients taking warfarin — "knowing that they were so inaccurate that they posed a risk of serious injury or even death to those who used them."

Physicians use results from the Alere INRatio System to adjust the dose of warfarin, an anticoagulant that prevents blood clots from growing. They regulate warfarin by keeping it within a therapeutic target range determined by an international normalized ratio, or INR, that the Alere system measures.

In the complaint, the plaintiffs said that after the US Food and Drug Administration inspected Alere's manufacturing plant in 2005, the agency issued the firm a warning letter for failing to report "known instances in which its device produced clinically significant inaccurate results, some of which may have caused or contributed to death or serious injury, or could do so in the future."

In April 2014, Alere voluntarly recalled certain INRatio Test Strips, but "this limited recall did not remedy the serious and continuing problems of inaccurate INR results," according to the complaint.

In December of that year, Alere initiated a voluntary recall of all INRatio Monitors, the INRatio 2 Monitors, and the INRatio Test Strips. However, Alere continued to advertise the system on its website for sale to the public, the complaint alleged, and the company failed to properly disclose to the public the full extent of the dangers potentially posed by using the systems.

The plaintiffs had sought class action status for the lawsuit, and damages.

On Wednesday, the federal court dismissed the case, saying the two parties had reached a settlement agreement. Terms of the agreement were not disclosed.