Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

DRG Salivary Progesterone HS ELISA- IVD for the determination of Recalled by DRG Instruments GmbH Due to Salivary Progesterone assay may observe a higher percentage...

Date: June 6, 2019
Company: DRG Instruments GmbH
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DRG Instruments GmbH directly.

Affected Products

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

Quantity: 8 Kits

Why Was This Recalled?

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.

Where Was This Sold?

Distribution to Canada

About DRG Instruments GmbH

DRG Instruments GmbH has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report