Z-0787-2019Class I

CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part...

Name: Z-0787-2019 CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part...
Creator: Terrific Care Llc
Published: 2018-12-20
License: https://open.fda.gov/license/

Terrific Care LLC / initiated 2018-12-20 / Terminated / root cause: manufacturing process

FDA source

TERRIFIC CARE LLC began a recall of 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... on 2018-12-20. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0787-2019
Classification: Class I
Status: Terminated
Initiated: 2018-12-20
Posted: 2019-02-01
Terminated: 2020-12-29
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.
Product code: GJS Test, Time, Prothrombin
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]. - 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 in commerce: 793 boxes
Distribution: Nationwide Distribution
Product codes and lots: All Lot Numbers sold by Terrific Care LLC dba Medex Supply

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0787-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0787-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-13	2019-02-01

Product code GJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)