# FDA recall Z-1184-2018

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2017-11-09.

## Product

Dimension Vista System LOCI 8 CALIBRATOR     The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System.

## Reason for recall

An increase in the number of failed calibration events or negative bias with Quality Control (QC) and patient samples when using Dimension Vista LOCI 8 Calibrator lot 7CD076 to calibrate Estradiol (E2) Assay.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Slovakia, Spain and Switzerland.

## Key facts

- **Recall number:** Z-1184-2018
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-09
- **Report date:** 2018-04-04
- **Termination date:** 2020-06-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2018

## Citation

> AI Analytics. FDA recall Z-1184-2018. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1184-2018. Source: US FDA. Licensed CC0.

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