Reported Mar 11, 2026 · Ongoing

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005

Is this the product you have?

  • Atellica CH Urine Albumin (UAlb)
  • Material Number11537225
Lot codes and dates
  • Material Number11537225
  • UDI-DI00630414611099
  • Lot NumbersAll lot numbers
Amount recalled
4,885 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.