FDAFDA · Food and drugs·Recall number Z-1240-2016
Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Published March 30, 2016 · Recall initiated: January 13, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Distributor
- Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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