Class 2 Device Recall VIDAS Testosterone

• Date Initiated by Firm: May 15, 2017
• Date Posted: June 29, 2017
• Recall Status: Terminated 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: 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