Siemens Atellica C-Reactive Protein Test May Give Wrong Results
Siemens Healthcare recalls Atellica CH Revised C Reactive Protein (RCRP) tests due to potential for incorrect results. Affected units have Siemens Material Number 11537223 and all lots.
Lower-risk recall
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Contact the company
What happened, in plain English
Siemens Healthcare is recalling Atellica CH Revised C Reactive Protein (RCRP) tests because software may cause incorrect results. This could lead to wrong medical diagnoses if used in testing. Read more at govinfonow.com/recall/52646-siemens-atellica-c-reactive-protein-test-may-give-wrong-results.
Source Summary by GovInfoNow · govinfonow.com/recall/52646-siemens-atellica-c-reactive-protein-test-may-give-wrong-results · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1551-2025
Cite this page
“Siemens Atellica C-Reactive Protein Test May Give Wrong Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52646-siemens-atellica-c-reactive-protein-test-may-give-wrong-results. Based on FDA recall #Z-1551-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1551-2025%22&limit=1).
Why it’s dangerous
The software in the test may flag results incorrectly, potentially causing false positive or negative outcomes. This could lead to wrong medical decisions if the test is used for diagnosis.
Who’s affected
Healthcare providers using the Atellica C-Reactive Protein tests with Siemens Material Number 11537223 are affected. Patients relying on these tests for medical diagnosis may be at risk of incorrect results.
How to tell if you have this one
Check for Siemens Material Number 11537223 on the test kit. All lots of this product are affected. The product is sold under the brand name Atellica CH Revised C Reactive Protein (RCRP).
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Test Kit Details
Look for Siemens Material Number 11537223 on the test kit label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong…” 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 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1551-2025 (March 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1551-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.