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Medication Safety Alerts

CoaguChek XS PT Test Strips Voluntary Recall

November 1, 2018

On November 1, 2018, Roche Diagnostics issued a voluntary recall of CoaguChek® XS PT 48 Test Strips, CoaguChek XS PT 6 Test Strips and CoaguChek® XS Test 24 Tests USA. This recall was issued due to inaccurate International Normalized Ratio (INR) test results, when compared to laboratory results.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of the affected products is provided here:

To see if you have affected product, please check the catalog reference number and the lot number. The lot number is printed on the test strip label, which is applied to the test strip box and the test strip vial.

If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots, stop using and discard any CoaguChek XS PT Test Strips from the affected lots. The FDA recommends that patients should contact their health care provider and patient self-testing service providers immediately to determine alternative test methods and address questions regarding their testing schedule. Please contact the pharmacy that filled your prescription for instructions about getting replacement product. The manufacturer states that unaffected CoaguChek XS PT Test Strips (Lot numbers 33449900 and higher) are now available in the market.

You should not continue to use a product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different product, please call your doctor.

CVS Caremark Response: If you are currently taking CoaguChek XS PT Test Strips, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking CoaguChek XS PT Test Strips and have questions regarding this recall, please call your doctor or call Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week toll-free at 1-800-428-4674 or visit www.coaguchek-usa.com/. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.

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