Siemens Healthcare recalls IMMULITE 2000 Estradiol tests that may give false high results, risking delayed cancer treatment. Affected units include specific catalog numbers and manufacturing lots.
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.
Siemens Healthcare is recalling IMMULITE 2000 Estradiol test systems that could produce falsely high estradiol results. This might cause doctors to delay or incorrectly treat breast cancer patients, especially those with hormone receptor positive cancer.
The test can give falsely elevated estradiol results, which might lead doctors to think a patient is pre-menopausal when they are actually post-menopausal. This could delay starting beneficial cancer treatment or cause unnecessary drug administration for hormone receptor positive breast cancer.
Patients using these estradiol tests for breast cancer treatment may be at risk if the test shows false high levels. Clinicians treating hormone receptor positive advanced or metastatic breast cancer are most affected.
Check for catalog numbers: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests), OUS: L2KE22 (200 tests) and L2KE26 (600 tests). The product was sold with manufacturing lots starting 501 and above.
Identify the catalog number and manufacturing lot number to confirm if your test system is affected.
The IMMULITE 2000 Estradiol tests may produce falsely elevated estradiol results, which could lead to delayed cancer treatment or unnecessary drug administration for hormone receptor positive breast cancer.
The official recall notice does not specify a remedy or action steps for affected units.
All kit lots beginning 501 and above.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1514-2020 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
