# FDA recall Z-2410-2019

> **DRG Instruments GmbH** · Class II · device recall initiated 2019-06-06.

## Product

DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva  REF: SLV-5911     in vitro diagnostic

## Reason for recall

Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.

## Distribution

Distribution to Canada

## Key facts

- **Recall number:** Z-2410-2019
- **Recalling firm:** DRG Instruments GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-06
- **Report date:** 2019-09-04
- **Termination date:** 2020-05-11

- **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-2410-2019

## Citation

> AI Analytics. FDA recall Z-2410-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2410-2019. Source: US FDA. Licensed CC0.

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