If you use a medical device to monitor levels of a blood thinner, the test strips could be bad.
The FDA says patients and doctors who use the strips to monitor levels of the blood thinner Warfarin shouldn't rely on the devices to adjust the drug dosage.
The recall involves more than a million packages of Coagucheck test strips distributed nationwide over the entire year.
Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. Today, the FDA announced this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death.
The FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they're using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.
Find the list of recalled strips HERE.
Photo Credit: FDA