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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Testosterone

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  Class 2 Device Recall VIDAS Testosterone see related information
Date Initiated by Firm May 15, 2017
Date Posted June 29, 2017
Recall Status1 Terminated 3 on June 11, 2020
Recall Number Z-2339-2017
Recall Event ID 77292
510(K)Number K021326  
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
Product VIDAS Testosterone, Ref 30418
Code Information Lots 1004878310 & 1005001080
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Debra Broyles
314-731-8805
Manufacturer Reason
for Recall		 Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Product Safety Notice was sent on 5/15/2017 to consignees. The Notice requested that they discontinue use and discard any remaining inventory of the product, and to identify any possible falsely over estimated results and determine appropriate actions if relevant. The Notice also included a response form to be returned to Biomerieux.
Quantity in Commerce 742
Distribution AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine
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 = BIOMERIEUX, INC.
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