Siemens Healthcare recalls Atellica CH Urine Albumin REF: 11537225 due to potential false low results for urea nitrogen and hemoglobin A1c tests, affecting diagnostic accuracy.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Siemens Healthcare is recalling Atellica CH Urine Albumin REF: 11537225 test kits because they may produce false low results for urea nitrogen and hemoglobin A1c tests. This could lead to incorrect health diagnoses if used without proper validation.
The test kits may produce falsely low results for urea nitrogen and hemoglobin A1c tests. This can cause incorrect health assessments if the results are used without verification. The issue affects diagnostic accuracy but does not involve immediate physical harm.
Users of Atellica CH Urine Albumin REF: 11537225 test kits may be affected. Laboratory staff and healthcare providers using these kits for urine albumin testing are most at risk of inaccurate results.
Check for the Atellica CH Urine Albumin REF: 11537225 product with lot numbers within expiry/UDI: 00630414611099. This recall covers specific test kits used in laboratory settings.
Verify the lot number on the test kit to confirm if it falls within the affected range: 00630414611099.
The Atellica CH Urine Albumin REF: 11537225 test kits with lot numbers within expiry/UDI: 00630414611099 are being recalled.
The test kits may produce falsely low results for urea nitrogen and hemoglobin A1c tests, which could lead to incorrect health diagnoses if not validated.
Check the lot number on the test kit to see if it falls within the affected range: 00630414611099. No specific action is required beyond verification.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2890-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2890-2026 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.
