The Recall Desk

FDA (Devices) recall action 84947

Siemens Healthcare Diagnostics, Inc. recalled 2 products on 2020-03-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-25
Critical
0
Units
8,385

Why these products were recalled

Due to high discordant Estradiol results which.potentially affects all patient populations, A falsely elevated estradiol level could lead a clinician to misinterpret a patient as pre-menopausal when truly post- menopausal. This may lead to delayed initiation of a potentially beneficial drug and/or administration of an unnecessary drug in the treatment for hormone receptor positive advanced or metastatic breast cancer.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-03-25

    Siemens IMMULITE 2000 Estradiol Test Kits Recalled for High Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol test kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in…
    Category
    Distribution
    37 states
  • HighFDA (Devices)··2020-03-25

    Siemens IMMULITE 1000 Estradiol Kits Recalled for Discordant Results

    Siemens Healthcare Diagnostics is recalling IMMULITE 1000 Estradiol kits due to high discordant results that may lead to misinterpretation of patient menopausal status.

    Product
    IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual…
    Category
    Distribution
    37 states