FDA Medical Device Recalls (openFDA)
TERRIFIC CARE LLC: CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
- Recall number
- Z-0787-2019
- Recalling firm
- TERRIFIC CARE LLC
- Product
- CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
- Status
- Terminated
- Initiated
- 2018-12-20
- Posted
- 2019-02-01
- Terminated
- 2020-12-29
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 793 boxes
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All Lot Numbers sold by Terrific Care LLC dba Medex Supply
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 3014100519
- Firm city
- Passaic
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28