Siemens Healthcare recalls ADVIA Centaur Enhanced Estradiol 500T test kits that may give falsely high estradiol readings, potentially leading to incorrect patient diagnoses. 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 can produce falsely elevated estradiol results. This could lead doctors to misinterpret patient test results and make incorrect medical decisions.
The test kits may produce falsely high estradiol readings in plasma samples. This could cause clinicians to misinterpret patient results, potentially leading to incorrect medical decisions or treatments.
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 incorrect diagnoses.
Check if you have the ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits. All lots are affected, and the unique identifiers include specific sequences like (01)00630414574646(10)14530079(17)20220304.
Look for the unique identifier sequence on the test kit packaging, such as (01)00630414574646(10)14530079(17)20220304.
No, the recall does not require stopping use. The test kits may produce inaccurate results, but the remedy is not specified in the recall notice.
The recall notice does not specify a remedy, so no action is required. However, you should verify the lot numbers to ensure you have affected kits.
All ADVIA Centaur Enhanced Estradiol (eE2) 500T test kits are affected. Check the unique identifier sequence on the packaging for specific codes like (01)00630414574646(10)14530079(17)20220304.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1024-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1024-2022 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.
