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DRG Instruments GmbH recalls DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usag
Recalled August 14, 2019 · FDA recall Z-2159-2019 · DRG Instruments
Hazard
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 · FDA Class II
Units
38 kits
Sold at
Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
Description
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
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
Manufacturer(s)
DRG Instruments GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →