Siemens Healthcare recalls Atellica IM aTPO Assay (Material Numbers 10995466 and 10995467) due to potential positive bias in patient results at low levels. Affected lots may show false positives in tests.
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Siemens Healthcare is recalling two specific Atellica IM aTPO Assay products because they may produce false positive results at low patient levels. This could lead to incorrect diagnoses if used without proper testing procedures.
The assay may show positive results at or below 60 U/mL when compared to other lots on the same analyzer. This positive bias could cause false positives in patient testing, potentially leading to incorrect diagnoses.
Lab users who purchased the Atellica IM aTPO Assay with Material Numbers 10995466 (100 tests) or 10995467 (500 tests) are most at risk. These products were sold with specific lot numbers.
Check for Material Numbers 10995466 (100 tests) or 10995467 (500 tests) on the product label. Affected lots have specific UDI-DI codes: 00630414597935 for 100 tests and 00630414597942 for 500 tests.
Verify the Material Number and UDI-DI code on the product label to confirm if it's affected.
The Atellica IM aTPO Assay may produce false positive results at or below 60 U/mL when compared to other lots on the analyzer, potentially leading to incorrect diagnoses.
Check for Material Numbers 10995466 (100 tests) or 10995467 (500 tests) with UDI-DI codes 00630414597935 or 00630414597942.
The recall does not specify a remedy, so contact Siemens Healthcare 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-3305-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3305-2024 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.
