News | Blood Testing | December 28, 2018

CoaguChek XS PT Test Strips Recalled for Inaccurately Reporting High INR

Affected strips were distributed directly to U.S. consumers by Terrific Care LLC/Medex Supply Dist Inc. between Dec. 27, 2017, and Dec. 15, 2018

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

Related Content

Validation Studies Confirm High Accuracy of Novel HART AI-Driven Blood Tests
News | Blood Testing | March 19, 2019
Prevencio Inc. announced data confirming the high accuracy of its artificial intelligence (AI)-driven, multiple-protein...
Abbott Point-of-Care Blood Test Speeds Heart Attack Diagnosis
News | Blood Testing | October 26, 2018
For someone experiencing cardiac symptoms in the emergency room, every minute matters as physicians determine whether...
New Noninvasive Blood Glucose Test as Effective as Finger Prick

Image courtesy of University of Missouri School of Medicine

News | Blood Testing | October 24, 2018
For those living with diabetes, monitoring blood glucose accurately is necessary to prevent diabetes-related...
Abbott Receives CE Mark for High Sensitive Troponin-I Test
News | Blood Testing | October 16, 2018
October 16, 2018 — Abbott announced that its High Sensitive Troponin-I...
AI-Driven Blood Test Accurately Diagnoses Peripheral Artery Disease in Diabetic Patient
News | Blood Testing | September 04, 2018
Prevencio Inc. announced new data demonstrating its HART PAD test accurately diagnoses peripheral artery disease (PAD)...
More Sensitive Blood Test Diagnoses Heart Attacks Faster
News | Blood Testing | August 06, 2018
August 6, 2018 — A new test to assess a whether or not someone is having a...
Singulex cTnl Assay Can Identify Presence, Severity of CAD in Stable, Symptomatic Outpatients
News | Blood Testing | March 26, 2018
March 26, 2018 — Measurement of cardiac troponin in stable patients with chest pain using the ultra-sensitive Singule
Florida Medical Center First in State to Offer High Sensitive STAT Blood Test
News | Blood Testing | September 07, 2017
In July, The Heart Institute at Florida Medical Center became the first hospital in the state of Florida to offer the U...
Patients With Low Corus CAD Test Score Less Likely to Undergo Cardiac Referra
News | Blood Testing | May 02, 2017
CardioDx Inc. recently announced the publication of results from the multi-center, community-based PRESET Registry in...
New Blood Test Predicts Major Cardiac Events Better Than Clinical Evaluation of Other Common Risk Factors
News | Blood Testing | April 28, 2017
Prevencio Inc. announced the publication of data demonstrating that a simple new blood test is more accurate than...
Overlay Init