Recall Z-0787-2019

Reason for recall

Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba MedEx Supply via website/telephone/facsimile.

FDA-determined cause: Nonconforming Material/Component

Action taken

On December 20, 2018, Terrific Care, LLC. / Medex Supply Dist, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter (dated 12/19/18) of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/telephone/facsimile orders. On December 21, 2018, Terrific Care, LLC / Medex Supply Dist, Inc. re-issued an Amended Press Release identifying affected Catalog Numbers and lots. On December 26, 2018, recall notices were issued to customers via email. On or about January 29, 2019, Terrific Care, LLC. / Medex Supply Dist, Inc. re-issued Urgent Medical Device Recall and Response Forms to customers. Actions Required: 1) Immediately stop using and quarantine all CoaguChek XS Test Strips sold by Terrific Care, LLC. / Medex Supply Dist, Inc. via website/phone orders/facsimile. 2) If you have product to return, please 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. 3) Include your order ID, and insert - Recall- in the email subject line. 4) Complete and return the attached response form via email. 5) For reimbursement, contact Terrific Care by phone at 888-433-2300 or by email at RMA@medexsupply.com. - Patients, caretakers and health care providers should switch to new batches of CoaguCheck XS P Test Strips. New batches should be obtained by contacting Roche Diagnostics Corporation at 1-800-428-4674. -Patients who are using devices affected by the recall should contact their health care providers immediately to determine an alternative testing method while waiting for replacement strips that are not affected.