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 serious injuries or deaths.
The FDA CoaguChek XS PT Test Strips Class I recall announcement includes this serious message: “Use of affected products may increase the risk of serious adverse health consequences, including death.” It goes on to provide this additional important information:
Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:
- Mechanical heart valve
- Atrial fibrillation and high-risk CHA2DS2-VASc scores
- Recent thromboembolic events
We are investigating possible legal compensation claims against the manufacturer Roche Diagnostics for patient injuries or deaths due to the use of these defective CoaguChek test devices.[View article in full at original source]
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