Lower riskMedical device recall · FDA · Published August 21, 2024
Siemens Atellica IM aTPO Assay Recall: Positive Bias in Patient Results
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 Atellica IM aTPO Assay Recall: Positive Bias in Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54187-siemens-atellica-im-atpo-assay-recall-positive-bias-in-patient. Based on FDA recall #Z-3305-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3305-2024%22&limit=1).
Siemens Healthcare Diagnostics, Inc. recalled Atellica IM aTPO Assay lots due to positive bias in patient results at and below the cut-off of 60 U/mL, according to the FDA on Aug. 21, 2024.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica IM aTPO Assay
Material Number: 10995466 (100 Test)
Material Number: 10995467 (500 Test)
Lot Numbers: 26098336, 26099336
The hazard
The recall addresses a positive bias in patient results at and below the cut-off of 60 U/mL with the listed lots when compared to alternate lots on the Atellica IM analyzer.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), Fujirebio Lumipulse pTau 217 Plasma Controls Recall (Dec. 11, 2025), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026).
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.
Recall number
Product, codes & lots
Quantity
Z-3304-2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test); UDI-DI: Material Number 10630886 (100 Test) - 00630414587837; Material Number 10630887 (500 Test) - 00630414587844; Lot Number: 26053337 26054337 26051337 26052337
5622 kits
Z-3305-2024
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test); UDI-DI: Material Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942; Lot Number: 26098336 26099336
9783 kits
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the Material Number and UDI-DI code on the product label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-3305-2024 (August 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3305-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.