Events

Safety Alert for ESTRADIOL IMMULITE 2000, model Kit for 200 tests; kit for 600 tests, class II, registration 10345160699, batch / series: Kit for 200 tests: 282; 283; 288; 290; 291; 294; 301; 302; 303; 305; 307; 308; 310; 311; 313; 314; 316; 317; 318; 320; 321; 322; 323; 325; 327; 328; 329; 332; 333; 334; 335; 337; 338; 340; 342; 343; 344; 345; 346; 347; 348; 349; 350; 351; 353; 354; 355; 357; 358; 360; 361; 362; 363; 364; 369. Kit for 600 tests: 282; 287; 290; 292; 293; 296; 297; 298; 303; 304; 305; 306; 309; 310; 313; 314; 316; 317; 320; 322; 323; 324; 326; 327; 329; 332; 333; 336; 338; 339; 342; 345; 347; 349; 350; 351; 353; 354; 356; 357; 361; 363; 364; 368; 369. /// ESTRADIOL - IMMULITE, model Kit for 100 tests, risk class II, registration 10345160711, lot / series: 332; 333; 335; 336; 337; 338; 339; 340; 341; 342; 343; 344; 345; 346; 347; 348; 350; 351; 352; 353; 354; 355; 358; 359; 360. /// ADVIA Centaur Enhanced Estradiol (eE2), model 100 tests; 500 tests, hazard class II, registration 10345161769, lot / series: 72030; 3575030; 11759018; 13170018; 13207031; 15117018; 18408031; 18426020; 19481020; 21058020; 23802021; 24639021; 28107022; 28194022; 31117023; 32682023; 35283024; 36441024; 37859024; 38443024; 39467025; 40609025; 4,151,3025; 4,250,5025; 4,417,5026; 4,483,5026; 4,634,026; 4,714,6026; 4,990,927; 5,088,9027; 5,287,7027; 5,336,2029; 5,438,5029; 5,543,9029; 7,755,9029; 2,850,3011; 82073011; 83233012; 87765014; 89433014; 89736030; 93183016; 95235017; 97087017; 97945017.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products Ltd.; Siemens Healthcare Diagnostics Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1800
  • Date
    2016-01-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    The health risk applies to all patients receiving fulvestrant. Cross-reaction may lead to falsely elevated estradiol results leading to an inappropriate clinical evaluation of estrogen status. Fulvestrant is used in the treatment of postmenopausal women in the recurrence of stage IV breast cancer positive for estrogen receptor. If the listed estradiol trials are used to assess the menopausal status of a given patient population, falsely elevated estradiol levels may lead the clinician to misinterpret this patient as premenopausal, possibly leading to altered use or even discontinuation of drug use potentially beneficial, or fulvestrant. If this has occurred, reassessing the patient's menopausal status by other means or using an alternative estradiol measure may be considered.
  • Reason
    Possibility of falsely elevated estradiol results due to cross-reactivity of fulvestrant in the estradiol assays of siemens healthcare diagnostics.
  • Action
    The field action code CC 16-03 initiated by Siemens addresses the sending of a Letter to the Client with risk classification II (situation in which there is a high probability that the use or exposure to a health product may cause a temporary health or reversible per treatment). Recommendation to users and patients: Because of the significant interference of fulvestrant with estradiol immunoassays, these assays should not be used for the monitoring of estradiol levels in patients receiving fulvestrant. For patients being treated with fulvestrant, the use of an alternative method such as Mass Spectrometry (LC-MS), which is expected to not be cross-reacted with fulvestrant, should be used to estradiol. Siemens oestradiol trials may continue to be used to report results from patients not on fulvestrant therapy.

Device

ESTRADIOL IMMULITE 2000, model Kit for 200 tests; kit for 600 tests, class II, registration 10345...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Products Ltd.; Siemens Health...
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA