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U.S. Department of Health and Human Services

Class 2 Device Recall DRG

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  Class 2 Device Recall DRG see related information
Date Initiated by Firm May 21, 2019
Create Date August 05, 2019
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-2159-2019
Recall Event ID 83183
510(K)Number K052649  
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
Product DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva
Catalog # SLV-3013

Product Usage:
The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Code Information Lot Numbers: 66K118, 66K019
Recalling Firm/
Manufacturer		 DRG Instruments GmbH
Frauenbergstr. 18
Marburg Germany
Manufacturer Reason
for Recall		 Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
FDA Determined
Cause 2		 Under Investigation by firm
Action DRG International issued notification via email on 5/21/19 advising of the problem, health risk and action to take: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products, 2. Please send back or discard all unused kits. 3. Please use the attached response form, fill, sign and send back to us.4. Please inform your customers and forward this letter and notice to persons who received the affected lots and request they fill out the form and return at once.5. Patient samples that have been determined with the affected lots should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: qa@drg-international.com and copy drqsupport@drginternational.com).
Quantity in Commerce 38 kits
Distribution Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland
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.
510(K) Database 510(K)s with Product Code = CDZ and Original Applicant = DRG INTL., INC.
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