Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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 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 doc

U.S. FDA — Device Enforcement · United States · 2018-12-20 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0787-2019
Date of alert: 2018-12-20
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: TERRIFIC CARE LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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