# FDA recall Z-0113-2019

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2018-07-24.

## Product

ADVIA Centaur CKMB Calibrator, Cat No. 09318028    Product Usage:  For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

## Reason for recall

A potential bias was identified with certain kits compared to the internal standards.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0113-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-24
- **Report date:** 2018-10-24
- **Termination date:** 2020-05-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Walpole, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0113-2019

## Citation

> AI Analytics. FDA recall Z-0113-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0113-2019. Source: US FDA. Licensed CC0.

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