Medical device recalls Moderate risk

DRG Instruments GmbH recalls Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrog…

Recall date
July 14, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2836-2018
FDA classification
Class II
Brand / firm
DRG Instruments GmbH
Sold / distributed
NJ; Germany, Belgium, Spain & Germany

Why it was recalled

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

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

What was recalled

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

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