FDA recall, , Moderate risk
Atellica CH Urine Albumin (UAlb)
Atellica CH Urine Albumin may report falsely depressed results for samples above 40.0 mg/dL.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc., of Tarrytown, New York, began a recall on January 20, 2026, of its Atellica CH Urine Albumin (UAlb) product, Material Number 11537225. The FDA added the recall to its Enforcement Report on March 2, 2026. The agency stated that falsely depressed UAlb patient results may occur, with affected samples having any urine albumin concentration above the measuring interval of greater than 40.0 mg/dL potentially reporting values between 6.2 mg/dL and 40.0 mg/dL.
The product was distributed nationwide in the US and worldwide, including Australia, Austria, Belgium, Brazil, Canada, Chile, 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, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- UDI-DI
- 11537225
- 00630414611099
- Lot code
- All lot numbers.
Recall details
- Company began the recall
- Sold in
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.
- Company
- Siemens Healthcare Diagnostics, Inc.Tarrytown, New York
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98370
- Recall number
- Z-1484-2026
- Quantity recalled
- 4,885 units
All recalls from Siemens Healthcare Diagnostics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
