Siemens Healthcare recalls Atellica IM Enhanced Estradiol (eE2) 100T test kits that may give falsely elevated estradiol results, potentially causing misdiagnosis. Affected kits have specific lot numbers and were sold with UDI codes starting with (01)00630414598857.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Siemens Healthcare is recalling Atellica IM Enhanced Estradiol (eE2) 100T test kits that may give falsely high estradiol results. This could lead doctors to misinterpret patient results and make incorrect medical decisions.
These test kits may produce false high estradiol results when used with plasma samples. If a doctor sees these results, they might incorrectly diagnose a patient's condition, potentially leading to inappropriate treatment.
Healthcare providers using these test kits for estradiol measurements may be affected. Patients with estradiol tests run on these kits could face misdiagnosis.
Check for lot numbers starting with (01)00630414598857 on the test kit packaging. The kits were sold with unique identifiers (UDI) showing specific dates and numbers.
Look for lot numbers starting with (01)00630414598857 on the test kit packaging.
No, but you should check the lot number to see if your kit is affected. If it is, contact Siemens Healthcare for instructions.
Contact Siemens Healthcare directly for guidance on what to do with the affected test kits.
Check the lot number on the kit packaging. Affected kits have lot numbers starting with (01)00630414598857.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1020-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1020-2022 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.
