Device product
IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders
Z-1243-2016
Product summary
- Event
- Event 73052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9334 units
- Official record key
device-enforcement:Z-1243-2016
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.