FDA recall Z-2836-2018

DRG Instruments GmbH · Class II · device

Product

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

Reason for recall

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

Distribution

NJ; Germany, Belgium, Spain & Germany

Key facts

Status
Terminated
Initiation date
2016-07-14
Report date
2018-08-22
Termination date
2020-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marburg, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2836-2018