Device 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).
Z-1801-2017
Product summary
- Firm
- BioMerieux SA
- Event
- Event 76727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 834 kits
- Official record key
device-enforcement:Z-1801-2017
Official wording
Reason: Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
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
Derived failure modes
-
Unknown
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.