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FDA-Device2026-03-11Class IIPROCESSING DEFECT

Siemens Atellica CH Urine Albumin test recalled for falsely low results

Siemens
FALSE CLAIMSNationwide distribution

Stop using Siemens Atellica CH Urine Albumin tests

Siemens Healthcare Diagnostics recalled its Atellica CH Urine Albumin test kits because they may report falsely low results for high-protein urine samples. If a sample contains more than 40.0 mg/dL of albumin, the test may incorrectly show a value between 6.2 and 40.0 mg/dL instead. This affects all lot numbers of Material Number 11537225 distributed worldwide.

  • Stop using Atellica CH Urine Albumin test kit (Material Number 11537225) immediately
  • Contact Siemens Healthcare Diagnostics for guidance on replacement or refund
  • Review recent test results from this kit with your healthcare provider if concerned about accuracy
  • Notify your laboratory director or compliance officer if your facility used this product
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.
Affected count
4,885 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1484-2026

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