More Than 1 Million Packages Of Defective Devices Used To Check INR For Warfarin May Cause Serious Injuries Or Death
In September 2018 Roche Diagnostics issued a voluntary recall of more than 1 million packages of the CoaguChek XS PT Test Strips that were sent out nationwide from January 2018 up to the date when Roche issued this CoaguChek recall.
On November 1, 2018, however, the severity and urgency of this CoaguChek INR test meter devices recall was increased when the FDA designated it a Class I recall. For medical devices, this is the most serious type of FDA recall, reserved for situations where use of the defective devices may cause serious injuries or deaths.
We get more of the basic facts from this FDA document, "Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results":
- Name and Version: CoaguChek XS PT Test Strips
- Lot numbers: [see full list on the CoaguChek FDA recall document]
- Models: CoaguChek XS PT Test 2x24 Strips, CoaguChek XS PT Test 6 Strips, CoaguChek XS Test 24 Tests USA
- Manufacturing and Distribution Dates: January 12, 2018 – October 29, 2018
- Devices Recalled in the U.S.: More than 1.1 million packages
- The lot number is printed on the test strip label, which is applied to the test strip box and the test strip vial.
As background, CoaguChek XS PT Test Strips are used with Roche INR Test Meters to monitor patient response to warfarin (also known by the brand names Coumadin and Jantoven), providing the test result in the form of the International Normalized Ratio, or INR. The INR is used by patients and physicians to determine if warfarin dosing is appropriate.
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In January 2018 Roche re-calibrated the CoaguChek XS PT Test Strips in to correspond to a newly released INR International Standard. According to the FDA, in the months following this re-calibration Roche Diagnostics has received reports of patients experiencing abnormally high or inaccurate INR test results when testing with CoaguChek strips.
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
For more about this recall of certain Roche Diagnostics test strip lots used with its CoaguChek test meter devices, see this November 1, 2018 FDA News Release, "FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin".
We are investigating possible legal compensation claims against the manufacturer Roche for patient injuries or deaths due to the use of these defective CoaguChek test devices.
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