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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