Z-2836-2018 Class II Terminated
FDA device recall Z-2836-2018 was initiated by DRG Instruments GmbH on July 14, 2016 and is designated Class II. Reason for recall: Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1. The recall status is terminated (terminated August 4, 2020). Affected quantity: 169 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- July 14, 2016
- Termination Date
- August 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 kits
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.
Distribution Pattern
NJ; Germany, Belgium, Spain & Germany
Code Information
Lot # 68K056 Exp. Date 2017-05