Device product
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Z-1241-2016
Product summary
- Event
- Event 73052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1945 units
- Official record key
device-enforcement:Z-1241-2016
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.