Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
FDA Recall Z-2836-2018 · Posted None
Recalling FirmDRG Instruments GmbH
Recall StatusTerminated
Product CodePEJ
Date Initiated2016-07-14
Date Terminated2020-08-04
Product Quantity169 kits
Reason for Recall
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
NJ; Germany, Belgium, Spain & Germany
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.