Siemens Atellica CH RCRP Test May Give False High Results
Siemens Healthcare recalls Atellica CH Revised C-Reactive Protein tests with potential for falsely elevated results. All units are affected. Contact for remedy.
Lower-risk recall
The potential for falsely elevated results.
What happened, in plain English
Siemens Healthcare is recalling Atellica CH Revised C-Reactive Protein (RCRP) tests due to a potential for falsely elevated results. This could lead to incorrect health diagnoses if used without proper validation. Read more at govinfonow.com/recall/1449358-siemens-healthcare-diagnostics-inc-recalls-atellica-ch-revised-c-reactive.
Source Summary by GovInfoNow · govinfonow.com/recall/1449358-siemens-healthcare-diagnostics-inc-recalls-atellica-ch-revised-c-reactive · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3335-2026
Cite this page
“Siemens Atellica CH RCRP Test May Give False High Results.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449358-siemens-healthcare-diagnostics-inc-recalls-atellica-ch-revised-c-reactive. Based on FDA recall #Z-3335-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3335-2026%22&limit=1).
Why it’s dangerous
The tests may produce falsely elevated results, which could lead to incorrect health diagnoses. This is a potential issue for labs and healthcare providers using the product for diagnostic purposes.
Who’s affected
Healthcare providers and labs using the Atellica CH RCRP tests may be affected. Patients relying on these tests for accurate health monitoring are at risk of incorrect results.
How to tell if you have this one
The product has Siemens Material Number (SMN): 11537223. All lots are affected. The product was distributed worldwide, including the US and many other countries.
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Product Details
Identify the Siemens Material Number (SMN): 11537223 on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark,…” 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 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-3335-2026 (August 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3335-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 14, 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.