Terrific Care/ Medex Supply has initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care/Medex Supply. The products have been found to inaccurately report high INR test results.

Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

This recall is related to the recent Roche Diagnostics Recall. Roche Diagnostics, the manufacturer of CoaguChek meters and test strips, recently calibrated the CoaguChek XS PT Test Strips to provide INR (International Normalized Ratio) test results that correspond to the most recent INR International Standard. Since this calibration, Roche Diagnostics has been informed of patients experiencing inaccurately high INR test results when testing with the affected.

Actions Required:

• Immediately stop using all CoaguChek XS Test Strips sold by Terrific Care/Medex Supply
• Returns: Send an E-Mail to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between the hours of 9:00 am - 5:00 pm, Monday - Thursday

Return Instructions:

• Please include the order ID and please put in the subject Recall
• Terrific Care/Medex Supply began distributing impacted products between 12/27/2017 through 12/15/2018 directly to consumers via courier service.

Terrific Care/Medex Supply voluntarily recalled product after becoming aware of consumer complaints.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

1. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
2. Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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