Siemens Healthcare recalls ADVIA Centaur aTPO Assay kits with specific material numbers and lot numbers due to potential positive bias in patient results at low levels.
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 ADVIA Centaur aTPO Assay kits that may show false positive results at low patient levels. This could lead to incorrect diagnoses if used with the Atellica IM analyzer.
The assay may show false positive results at or below 60 U/mL when compared to other lots on the Atellica IM analyzer. This could lead to incorrect patient diagnoses if the test is used with the Atellica IM analyzer.
Lab users who have the specific ADVIA Centaur aTPO Assay kits with material numbers 10630886 (100 tests) or 10630887 (500 tests) and the listed lot numbers are affected. Healthcare professionals using these kits with the Atellica IM analyzer are most at risk.
Check for material numbers 10630886 (100 tests) or 10630887 (500 tests) and lot numbers 26053337, 26054337, 26051337, or 26052337 on the kit packaging.
Verify the material number and lot number on the kit packaging to confirm if it is recalled.
The kits may show false positive results at or below 60 U/mL when compared to other lots on the Atellica IM analyzer.
Material numbers 10630886 (100 tests) and 10630887 (500 tests) with lot numbers 26053337, 26054337, 26051337, or 26052337.
Incorrect diagnoses could occur if the test shows a positive result at low patient levels when compared to the Atellica IM analyzer.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-3304-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-3304-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
