# FDA recall Z-0360-2019

> **Roche Diagnostics Corporation** · Class I · device recall initiated 2018-09-13.

## Product

CoaguChek¿ XS System Prothrombin time test:  CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;  CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160;  CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;

## Reason for recall

Abnormally high INR test results with the affected CoaguChek test strips

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0360-2019
- **Recalling firm:** Roche Diagnostics Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-13
- **Report date:** 2018-11-14
- **Termination date:** 2020-10-16

- **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-0360-2019

## Citation

> AI Analytics. FDA recall Z-0360-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0360-2019. Source: US FDA. Licensed CC0.

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