Siemens recalls Atellica IM HER-2/neu assay kits that may produce false positive or negative results due to inaccurate Upper Limit of Normal measurements.
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.
Siemens is recalling Atellica IM HER-2/neu assay kits and calibrators that could give false positive or negative results. This means test results might be inaccurate, which could affect medical decisions.
The assay kits have an inaccurate Upper Limit of Normal (ULN) value, which can cause the test to produce false positive or false negative results. This means medical decisions based on these tests might be incorrect.
Users of these specific assay kits and calibrators for in vitro diagnostic testing are affected. Medical labs using these products for HER-2/neu testing are most at risk.
Check for the catalog numbers SMN 10995591, SMN 10995592, SMN 10308994, or SMN 10308993. Look for specific UDI codes listed in the recall notice.
Verify your kit's catalog number and UDI codes against the list provided in the recall notice.
Siemens confirmed that the Upper Limit of Normal (ULN) value in the instructions for use was no longer achieved, which could lead to false positive or false negative results.
No, the recall does not require immediate discontinuation. Users should check their product details and follow the provided steps to verify if they have affected items.
Check your product's catalog number and UDI codes against the list in the recall notice. If you have affected items, contact Siemens for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0115-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0115-2021 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.
