Z-0787-2019 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2019
- Initiation Date
- December 20, 2018
- Termination Date
- December 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 793 boxes
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution
Code Information
All Lot Numbers sold by Terrific Care LLC dba Medex Supply