# FDA recall Z-2836-2018

> **DRG Instruments GmbH** · Class II · device recall initiated 2016-07-14.

## Product

Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

## Reason for recall

Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.

## Distribution

NJ; Germany, Belgium, Spain & Germany

## Key facts

- **Recall number:** Z-2836-2018
- **Recalling firm:** DRG Instruments GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-07-14
- **Report date:** 2018-08-22
- **Termination date:** 2020-08-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marburg, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2836-2018

## Citation

> AI Analytics. FDA recall Z-2836-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2836-2018. Source: US FDA. Licensed CC0.

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