CoaguChek XS PT Test Strips Recalled for Inaccurately Reporting High INR

December 28, 2018 —Terrific Care LLC. / Medex Supply Dist Inc. initiated a nationwide recall on Dec. 19 of Roche CoaguChek test strips, as said products have been found to inaccurately report high INR test results. This recall only includes CoaguChek test strips distributed directly to U.S. consumers by Terrific Care LLC. / Medex Supply Dist Inc via its website/phone calls/facsimal of all catalog/REF numbers that do not end in 160.

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, the manufacturer of CoaguChek meters and test strips. The CoaguChek test strips distributed by Terrific Care LLC./Medex Supply Dist. Inc. include Catalog/REF numbers that were not included in the recent Roche recall because these items were not distributed by Roche Diagnostics in the United States.

Terrific Care, LLC. / Medex Supply Dist, Inc. began distributing impacted products between Dec. 27, 2017, through Dec. 15, 2018, directly to consumers via courier service.

Terrific Care, LLC. / Medex Supply Dist, Inc. voluntarily recalled product after becoming aware of consumer complaints.

Consumers are recommended to Immediately stop using all CoaguChek XS Test Strips listed above and purchased directly from Terrific Care LLC. dba MedEx Supply.

For returns, users should send an e-mail to [email protected] or call a customer service specialist at 888-433-2300 between the hours of 9 a.m.-5 p.m., Monday-Thursday. Users should return impacted strips directly to Terrific Care LLC, 61 Willet Street, Passaic, N.J., 07055-1971.

Adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

For more information: www.fda.gov