# FDA recall Z-2159-2019

> **DRG Instruments GmbH** · Class II · device recall initiated 2019-05-21.

## Product

DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva  Catalog # SLV-3013     Product Usage:  The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

## Reason for recall

Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower

## Distribution

Worldwide Distribution - US Nationwide CA, MI  Foreign:  Canada, Brazil, China, Poland

## Key facts

- **Recall number:** Z-2159-2019
- **Recalling firm:** DRG Instruments GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-08-14
- **Termination date:** 2020-05-29

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2019

## Citation

> AI Analytics. FDA recall Z-2159-2019. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2159-2019. Source: US FDA. Licensed CC0.

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