# FDA recall Z-0804-2021

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2020-12-02.

## Product

CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.     Catalog 04837738001

## Reason for recall

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

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0804-2021
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-02
- **Report date:** 2021-01-13
- **Termination date:** 2022-06-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2021

## Citation

> AI Analytics. FDA recall Z-0804-2021. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0804-2021. Source: US FDA. Licensed CC0.

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