10 Biggest Medical Device Recalls of 2016—Alere10 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.
December 2, 2016
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]
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