Siemens Healthcare recalls Atellica CH Urine Albumin (UAlb) with material number 11537225 due to potential false low results in urine albumin tests. All units are affected.
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Siemens Healthcare is recalling its Atellica CH Urine Albumin (UAlb) test device because it may show falsely low urine albumin levels. This could lead to incorrect health assessments if samples have high albumin concentrations.
The device may show urine albumin levels as low as 6.2 mg/dL when the actual concentration is above 40.0 mg/dL. This can cause false negatives in detecting high albumin levels, which might miss serious health conditions.
Users of the Atellica CH Urine Albumin test device with material number 11537225 are affected. People testing urine for albumin levels at home or in clinics may be at risk of inaccurate results.
Check for the material number 11537225 on the device. All lot numbers are affected, so every unit of this product is included in the recall.
Look for the material number 11537225 on the Atellica CH Urine Albumin device.
The device may show false low results but does not pose a direct safety risk. It could lead to inaccurate health assessments.
Check for the material number 11537225 on the device. All lot numbers are affected.
The recall does not specify a remedy, so no action is required beyond checking if you have the device.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2026 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1484-2026 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.
