FDA issues Class I recall for Roche Diagnostics ’ warfarin test strips

The FDA today issued a Class I recall for certain lots of Roche Diagnostics‘ warfarin test strips used with the CoaguCheck test meter devices.
Roche voluntarily recalled the strips in September, warning that for patients and doctors who use at-home devices to monitor levels of the blood thinner, the devices may yield inaccurate results. The FDA said today that the devices should not be used to adjust drug dosages.
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Source: Mass Device - November 2, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Diagnostics Food & Drug Administration (FDA) Pharmaceuticals Recalls Regulatory/Compliance Vascular Wall Street Beat Roche Diagnostics Source Type: news