Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225
- Recalling company
- Siemens Healthcare Diagnostics, Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 6, 2026
- Reported
- Aug 12, 2026
- Distribution
- 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.¿
- Status
- Ongoing
- Quantity
- 7018 units
- Lot / codes
- All Lots within expiry/UDI: 00630414611099
- Company location
- Tarrytown, NY
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2890-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2890-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.