medical Class II Updated 2019-08-14

DRG Instruments GmbH recalls DRG Salivary Testosterone ELISA- IVD for the detection of Te

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 66K118, 66K019
View official government recall

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