DRG Instruments GmbH recalls DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: T…

Recall date

May 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2159-2019

FDA classification

Class II

Brand / firm

DRG Instruments GmbH

Sold / distributed

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

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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