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U.S. Department of Health and Human Services

Class 2 Device Recall Salivary Estradiol ELISA

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  Class 2 Device Recall Salivary Estradiol ELISA see related information
Date Initiated by Firm July 14, 2016
Create Date August 16, 2018
Recall Status1 Terminated 3 on August 04, 2020
Recall Number Z-2836-2018
Recall Event ID 80575
Product Classification salivary estriol test - Product Code PEJ
Product Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Code Information Lot # 68K056 Exp. Date 2017-05
Recalling Firm/
Manufacturer		 DRG Instruments GmbH
Frauenbergstr. 18
Marburg Germany
Manufacturer Reason
for Recall		 Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 169 kits
Distribution NJ; Germany, Belgium, Spain & Germany
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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