Recall Z-0787-2019— TERRIFIC CARE LLC
Class I · Terminated
Class I FDA medical device recall by TERRIFIC CARE LLC, initiated 2018-12-20, terminated 2020-12-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- TERRIFIC CARE LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-12-20
- Terminated
- 2020-12-29
- Firm location
- Passaic, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.