BioMerieux SA: Medical Device Recall in 2017 - (Recall #: Z-1801-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 17, 2017

Date Posted: April 19, 2017

Recall Number: Z-1801-2017

Event ID: 76727

Reason for Recall:

Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.

Status: Terminated

Product Quantity: 834 kits

Code Information:

Lots 1005081700, 1005172850 & 1005359170

Distribution Pattern:

Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA

Voluntary or Mandated:

Voluntary: Firm initiated