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

Recall Z-0803-2021 — CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)

U.S. FDA — Device Enforcement · United States · 2020-12-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0803-2021
Date of alert: 2020-12-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Diagnostics Operations, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04837975001

Reported risk: Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

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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