Siemens Healthcare recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests with material number 11097543 due to potential false low results in patient testing.
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests that may give false low results in patient testing. This could lead to inaccurate quality control or calibration results, affecting diagnosis and treatment decisions.
The test may produce false low results in patient testing, which could lead to inaccurate quality control or calibration results. This might affect the accuracy of diagnoses and treatment decisions if the test is used without proper calibration.
Healthcare facilities using Siemens Atellica UCFP tests with material number 11097543 are affected. Patients receiving these tests may have inaccurate results if the test is used incorrectly.
Check for the material number 11097543 on the test kit. The product is sold under the Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) name with test code UCFP.
Look for the material number 11097543 on the test kit label.
The test may produce false low results in patient testing, which could lead to inaccurate quality control or calibration results.
Check the test kit for the material number 11097543. If you have this number, contact Siemens Healthcare for further instructions.
No serious injury risk is described in the recall notice. The hazard is limited to potential inaccurate test results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2542-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2542-2025 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.
