Device product
IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders
Z-1242-2016
Product summary
- Event
- Event 73052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9251 units
- Official record key
device-enforcement:Z-1242-2016
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.