DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany Recalls

Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.

On July 16, 2016, DRG Instruments GmbH emailed customers informing them that they might face a bad differentiation of Standard 0 and Standard 1 Salivary Estradiol kits. Customers were encouraged inspect stock, quarantine and discontinue use of the product. In case the kit was already used, customers were advised to re-check the data and re-run the samples as prevention.

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

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