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U.S. Department of Health and Human Services

Class 2 Device Recall VIDAS Estradiol II (E2 II)

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  Class 2 Device Recall VIDAS Estradiol II (E2 II) see related information
Date Initiated by Firm March 17, 2017
Date Posted March 20, 2017
Recall Status1 Terminated 3 on February 16, 2022
Recall Number Z-1801-2017
Recall Event ID 76727
510(K)Number K955647  
Product Classification Radioimmunoassay, estradiol - Product Code CHP
Product VIDAS Estradiol II, Ref 30431-01, 60 tests
The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
Code Information Lots 1005081700, 1005172850 & 1005359170
Recalling Firm/
BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information Contact Debra Broyes
Manufacturer Reason
for Recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
FDA Determined
Cause 2
Device Design
Action bioMerieux sent an Important Product Safety Notice A Product Safety Notice to all affected customers on March accounts on March 17, 2017, informing them not to use VIDAS Estradiol II test to test estradiol level in patients under Fulvestrant therapy. The letter did not request return of any of the product, and requested that they return an acknowledgement form acknowledging receipt of the notice and that they have followed the instructions and implemented the actions in the field notice. Customers with questions were instructed to contact their bioMerieux Customers Service representative. For questions regarding this recall call 314-731-8805.
Quantity in Commerce 834 kits
Distribution Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
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 = CHP and Original Applicant = BIOMERIEUX VITEK, INC.