# FDA recall Z-3187-2024

> **Roche Diagnostics Operations, Inc.** · Class II · device recall initiated 2024-08-15.

## Product

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma.  Catalog Number: 07190794190

## Reason for recall

Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-3187-2024
- **Recalling firm:** Roche Diagnostics Operations, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-15
- **Report date:** 2024-10-02

- **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-3187-2024

## Citation

> AI Analytics. FDA recall Z-3187-2024. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-3187-2024. Source: US FDA. Licensed CC0.

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