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.
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
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.
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.
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.
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).
Look for Siemens Material Number 11537223 on the test kit label.
The product may give incorrect results, so it should not be used until the recall is addressed.
Check for Siemens Material Number 11537223 on the test kit. All lots of this product are affected.
The recall does not specify a remedy, so contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1551-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1551-2025 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.
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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.
