Lower riskMedical device recall · FDA · Published August 25, 2020
Siemens Atellica HER-2/neu Assay Kits May Give False Results
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.
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc333 Coney St · East Walpole, MA 02032-1516
“Siemens Atellica HER-2/neu Assay Kits May Give False Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64436-siemens-atellica-her-2-neu-assay-kits-may-give-false. Based on FDA recall #Z-0115-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0115-2021%22&limit=1).
The FDA announced on 2020-08-25 that Siemens Healthcare Diagnostics, Inc. is recalling specific Atellica IM and ADVIA Centaur HER-2/neu assay kits and calibrators because the claimed Upper Limit of Normal was not achieved. This defect can potentially result in false positive or false negative results.
How to tell if you have it
Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591
Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use was no longer achieved. This can potentially result in false positive or false negative results.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2017-06-07. Other recent recalls of similar products include Siemens Atellica CH RCRP Test May Give False High Results (2026-08-17), Beckman Coulter Emit 2000 Quinidine Assay Recall (2026-07-13), and Siemens Atellica CH Urine Albumin Recall (2026-07-06). Other recent recalls of similar products include Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15), Magellan LeadCare II Blood Lead Test Kits (2026-03-13), and Siemens Healthineers Immulite 2000 Syphilis Screen Recall (2026-07-13).
How to tell if you have this one
Check for the catalog numbers SMN 10995591, SMN 10995592, SMN 10308994, or SMN 10308993. Look for specific UDI codes listed in the recall notice.
Brand
Siemens Healthcare
Product
Siemens Healthcare Diagnostics, Inc recalls Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify your kit's catalog number and UDI codes against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
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-0115-2021 (August 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0115-2021 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.