Siemens Healthcare recalls IMMULITE 1000 Estradiol test kits that may give falsely high estradiol results, potentially delaying cancer treatment for hormone receptor positive breast cancer patients.
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 1000 Estradiol test kits that could show falsely high estradiol levels. This might cause doctors to delay giving patients life-saving breast cancer treatments or give unnecessary medications.
The test may produce falsely elevated estradiol results, which could lead doctors to think a patient is pre-menopausal when they are actually post-menopausal. This might cause delays in starting effective breast cancer treatment or unnecessary medication.
Patients using the IMMULITE 1000 Estradiol test kits for hormone receptor positive breast cancer treatment may be at risk of delayed or unnecessary treatment. Clinicians using the test kits for diagnosis could misinterpret results.
Check for the catalog number US: LKE21(D) or OUS: LKE21 on the test kit. The test kits were sold with lot numbers starting from 501 and above.
Look for the catalog number US: LKE21(D) or OUS: LKE21 on the test kit label.
The test may show falsely high estradiol levels, which could lead doctors to delay cancer treatment or give unnecessary medications for hormone receptor positive breast cancer patients.
Check for the catalog number US: LKE21(D) or OUS: LKE21 on the test kit, and ensure it was sold with lot numbers starting from 501 and above.
The recall does not specify a stop-use action, so you can continue using it if you have the test kit but should check for the catalog number and lot number.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1513-2020 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.
