Device product
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Z-2836-2018
Product summary
- Event
- Event 80575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 169 kits
- Official record key
device-enforcement:Z-2836-2018
Official wording
Reason: Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
Code information: Lot # 68K056 Exp. Date 2017-05
Distribution pattern: NJ; Germany, Belgium, Spain & Germany
Derived failure modes
-
Unknown
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.