Device 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.
Z-0787-2019
Product summary
- Event
- Event 81857
- Status
- Terminated
- Classification
- Class I
- Quantity
- 793 boxes
- Official record key
device-enforcement:Z-0787-2019
Official wording
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.
Code information: All Lot Numbers sold by Terrific Care LLC dba Medex Supply
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
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.