Atellica CH Urine Albumin REF: 11537225 recall (Siemens Healthcare Diagnostics, Inc.)
Medical deviceClass IIOngoing
Summary: Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic. Reason: Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
What is being recalled
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Why
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.¿ (states named: Puerto Rico)
How to tell if yours is affected
All Lots within expiry/UDI: 00630414611099
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2890-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 6, 2026 |
| Reported | August 12, 2026 |
| Company | Siemens Healthcare Diagnostics, Inc. |
| Company location | Tarrytown, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7018 units |
More recalls from Siemens Healthcare Diagnostics, Inc. · all medical device recalls · recalls from July 2026