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Roche CoaguChek Recall Due To Erroneous Test Strips INR Level Results

November 7, 2018 By Law Offices of Thomas J. Lamb, P.A.

On November 1, 2018 the FDA issued a Class I recall for more than 1 million packages of CoaguChek XS PT Test Strips that were sent out nationwide from January 2018 to the end of October 2018. For medical devices, this Class I designation is the most serious type of FDA recall, reserved for situations where use of the defective devices may cause … [Read more...]

Filed Under: Unsafe Medical Devices Tagged With: CoaguChek XS PT Test Strips, FDA Recalls

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