FDA Recall
Terminated
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Recall: Z-2836-2018
·
Initiated July 14, 2016
Recall
- Recall Number
- Z-2836-2018
- Event Number
- 80575
- Firm
- DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany
- FEI Number
- 3002800697
- Product Code
- PEJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 14, 2016
- Terminated
- August 4, 2020
Description
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.
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.
Distribution
NJ; Germany, Belgium, Spain & Germany
Quantity
169 kits