Siemens Healthcare recalls Atellica IM Enhanced Estradiol 500T test kits due to potential false high estradiol readings, which could lead to misdiagnosis. Affected lots include specific UDI codes from March 2022 to November 2022.
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Siemens Healthcare is recalling its Atellica IM Enhanced Estradiol (eE2) 500T test kits because they may produce falsely elevated estradiol results. This could lead doctors to misinterpret patient results, potentially causing incorrect treatment decisions.
The test kits may give false high estradiol readings when used with plasma samples. This could cause doctors to misinterpret patient results, leading to incorrect treatment decisions.
Patients using the Atellica IM Enhanced Estradiol 500T test kits for estradiol testing may be affected. Women undergoing hormone level checks are most at risk of misdiagnosis.
Check the product label for the UDI codes listed: (01)00630414598864(10)10054080(17)20220303, (01)00630414598864(10)10979086(17)20221107, (01)00630414598864(10)53378082(17)20220521, and (01)00630414598864(10)70532084(17)20220804. All lots from March 2022 to November 2022 are affected.
Look for the UDI codes listed in the recall notice to confirm if your kit is affected.
The Atellica IM Enhanced Estradiol 500T test kits may produce falsely elevated estradiol results, which could lead to misdiagnosis.
Check the product label for the UDI codes listed in the recall notice to see if it is affected. If affected, contact Siemens Healthcare for instructions.
The affected kits were sold from March 2022 to November 2022, as indicated by the UDI codes.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1021-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1021-2022 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.
