FDA-Device2019-02-13Class I
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.
TERRIFIC CARE LLC
Hazard
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.
Sold states
Nationwide Distribution
Affected count
793 boxes
Manufactured in
61 Willet St, Bldg A-1, Fl 2, Passaic, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0787-2019Don't want to check this manually?
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