Z-1801-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- March 17, 2017
- Termination Date
- February 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 834 kits
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).
Reason for Recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
Code Information
Lots 1005081700, 1005172850 & 1005359170