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).
FDA Recall Z-1801-2017 · Posted 2017-03-20
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Recalling FirmBioMerieux SA
Recall StatusTerminated
Product CodeCHP
Date Initiated2017-03-17
Date Terminated2022-02-16
Product Quantity834 kits
Reason for Recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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