# FDA recall Z-0515-2018

> **Siemens Healthcare Diagnostics, Inc** · Class II · device recall initiated 2017-06-07.

## Product

ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack.  Siemens Material Number (SMN): 10379810, 10379811, 10697756.

## Reason for recall

Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).

## Distribution

US and OUS.

## Key facts

- **Recall number:** Z-0515-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2018-02-14
- **Termination date:** 2019-05-08

- **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-0515-2018

## Citation

> AI Analytics. FDA recall Z-0515-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0515-2018. Source: US FDA. Licensed CC0.

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