Siemens Healthcare recalls Atellica IM Enhanced Estradiol (eE2) 500T test kits due to potential false high estradiol results in blood tests, which could lead to misdiagnosis. Affected lots include all units with specific UDI codes.
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 can give falsely high estradiol results in blood tests. This risk could lead doctors to misinterpret patient results and make incorrect medical decisions.
The test kits can produce false high estradiol readings when used with plasma specimens. This could cause doctors to misinterpret patient results, potentially leading to incorrect medical decisions or treatments.
Patients using the Atellica IM Enhanced Estradiol (eE2) 500T test kits for estradiol blood tests. Clinicians who rely on these results for diagnosis may be at risk of misinterpreting patient health conditions.
Check for the product name 'Atellica IM Enhanced Estradiol (eE2) 500T' on the test kit. All lots are affected, including units with UDI codes starting with (01)00630414293639(10)01380084(17)20220804 or (01)00630414293639(10)20299080(17)20220303.
Look for the product name 'Atellica IM Enhanced Estradiol (eE2) 500T' and the UDI codes listed in the recall notice.
No, the recall does not require stopping use. The test kits can still be used but may give false high results.
Check the label for the UDI codes listed in the recall notice. If your kit matches, contact Siemens Healthcare for guidance.
The recall states a risk of misinterpretation, not direct harm. Serious injury is not mentioned in the hazard description.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1022-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1022-2022 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.
