FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Brand
DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany
UPC
Lot # 68K056 Exp. Date 2017-05

Units Affected

169 kits