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 Testosterone ELISA- IVD for the detection of Testerone Recalled by DRG Instruments GmbH Due to Salivary assay may observe a higher percentage of...

Date: May 21, 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 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

Quantity: 38 kits

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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