FDA Recalls CoaguChek Test Strips Used To Monitor Patients on Warfarin

According to the FDA, CoaguChek test strips manufactured by Roche Pharmaceuticals and distributed by Terrific Care/Medex Supply LLC  “may provide inaccurate results and should not be relied upon when adjusting drug dosage.” Incorrect results could result in patients being prescribed too much or too little warfarin and increase the risk for dangerous blood clots.

This is not the first recall for these products. In fact, in November, the same products were recalled—also due to inaccurate test results.

What are CoaguChek test strips?

CoaguChek test strips are used with CoaguChek meter devices to monitor how patients on the blood thinner, warfarin (Coumadin, Jantoven), are responding to the medication. CoaguChek devices are commonly used at home or in doctors’ offices.

Using a small blood sample from a finger prick, CoaguChek takes a reading of a patient’s INR (international normalized ratio), a measure of how long it takes for blood to clot. For patients on warfarin, this reading helps doctors determine if the medication is working or if dosing needs to be changed to properly prevent blood clots.

What is the FDA doing about this recall?

The FDA is warning patients and healthcare providers that the CoaguChek test strips manufactured by Roche and distributed by Terrific Care/Medex Supply LLC may provide inaccurate results that should not be relied upon to adjust warfarin dosing. Additionally, the FDA is taking steps to ensure that the affected test strips are removed from the market.

What do I do If I think I have a recalled product?

If you think you have recalled CoaguChek test strips, stop using them immediately and contact your doctor or healthcare provider. They will be able to advise you on alternative test methods to use in the meantime.

Always inspect your medical devices and medications, including all related packaging. If you ever notice that something doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations. For more information about what to do in case of a drug recall, read our blog post here.

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