Z-1801-2017Class II

VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the...

Name: Z-1801-2017 VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the...
Creator: BioMerieux SA
Published: 2017-03-17
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2017-03-17 / Terminated / root cause: design

FDA source

BioMerieux SA began a recall of 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... on 2017-03-17. FDA classified it as Class II and gives the reason as "Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1801-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Posted: 2017-03-20
Terminated: 2022-02-16
Recalling firm: bioMerieux, Inc.
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).
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Lots 1005081700, 1005172850 & 1005359170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1801-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1801-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-12

Product code CHP

K955647Class IVidas Estradiol II (E2ii) AssayBiomerieux Vitek, Inc. / cleared 1996-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)