FDA recall, , Moderate risk
Siemens Healthcare Diagnostics Atellica CH Urine Albumin
Atellica CH Urine Albumin tests may cause falsely depressed urea nitrogen and hemoglobin A1c results.
Summary by Recall Canary from the FDA notice
What happened
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urine Albumin, an in vitro diagnostic, because processing these tests on Atellica CH and Atellica CI analyzers may lead to falsely depressed Atellica CH Urea Nitrogen results, falsely depressed Atellica CH Enzymatic Hemoglobin A1c results, and increased rate of reaction cuvette QC failures with delayed results due to QC failures. The recall began July 6, 2026, and was added to the FDA's Enforcement Report on August 5, 2026.
The product was distributed worldwide, including US Nationwide, Puerto Rico, and countries such as Australia, Canada, Germany, and the United Kingdom. The recall covers 7018 units.
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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
- UDI-DI
- 00630414611099
- Lot code
- All Lots within expiry/UDI: 00630414611099
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, 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
- 99389
- Recall number
- Z-2890-2026
- Quantity recalled
- 7018 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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
