Device product
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.
Z-1240-2016
Product summary
- Event
- Event 73052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33604 units
- Official record key
device-enforcement:Z-1240-2016
Official wording
Reason: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Code information: All lots
Distribution pattern: 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.
Derived failure modes
-
Unknown
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.