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10 Biggest Medical Device Recalls of 2016—Alere

AlereDevice: Alere planned to take the INRatio and INRatio2 PT/INR Monitoring System, including INRatio Test Strips, off the market and to stop manufacturing the product.

Recall reason: According to information on the FDA recall page, "the INRatio System may generate an incorrect low result . . . If an incorrect low INR result is acted upon . . . the patient may be at risk of major or fatal bleeding."

When recall was initiated: July 11, 2016

Number of U.S. units impacted: 125,576 units

For more information, visit the FDA Recall page.


[Image courtesy of ALERE]

Take the Medical Innovation Tours during the BIOMEDevice San Jose Conference and Expo, December 7-8.
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