Siemens Healthcare recalls ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits due to potential false high estradiol results, which could lead to misdiagnosis. All units are affected.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Siemens Healthcare is recalling all ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits because they may give falsely high estradiol results. This could cause doctors to misinterpret patient results and make incorrect treatment decisions.
The test kits may produce false high estradiol results when used with plasma specimens. This could lead doctors to misinterpret patient results, potentially causing incorrect treatment decisions.
Healthcare providers using the ADVIA Centaur eE2 500T test kits for estradiol testing are affected. Patients receiving results from these kits may be at risk of misdiagnosis.
Check if you have the ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits. All lots are affected, so all units are included in this recall.
Look for the lot number on the test kit packaging to confirm if it is affected.
No, the recall does not require stopping use. The kits may need to be checked for the lot number to confirm if they are affected.
The recall does not specify a remedy, so you should check the lot number to determine if the kit is affected.
All ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits are affected, so any kit with this product name is included in the recall.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1025-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1025-2022 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.
