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U.S. Department of Health and Human Services

Class 2 Device Recall DRG Instruments Salivary Progesterone HS ELISA

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  Class 2 Device Recall DRG Instruments Salivary Progesterone HS ELISA see related information
Date Initiated by Firm June 06, 2019
Create Date August 28, 2019
Recall Status1 Terminated 3 on May 11, 2020
Recall Number Z-2410-2019
Recall Event ID 83177
Product Classification Radioimmunoassay, progesterone - Product Code JLS
Product DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva
REF: SLV-5911
in vitro diagnostic
Code Information Lot Number:315K029
Recalling Firm/
Manufacturer		 DRG Instruments GmbH
Frauenbergstr. 18
Marburg Germany
Manufacturer Reason
for Recall		 Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.
FDA Determined
Cause 2		 Under Investigation by firm
Action DRG International issued notification letter via email dated 5/22/19 advising of the problem, health risk and Action to be taken by Distributors and End-users: 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 lot and request they fill out the form and return at once. 5. Patient samples that have been determined with the affected lot 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 drgsupport.@drginternational.com).
Quantity in Commerce 8 Kits
Distribution Distribution to Canada
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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