Recall Z-2836-2018— DRG Instruments GmbH
Class II · Terminated
Class II FDA medical device recall by DRG Instruments GmbH, initiated 2016-07-14, terminated 2020-08-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.. Reason: Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1..
- Recalling firm
- DRG Instruments GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-14
- Terminated
- 2020-08-04
- Firm location
- Marburg, Germany
Product description
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.
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