FDAFDA recall Z-2890-2026 · Aug 12, 2026
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urine Albumin REF: 11537225 recall
Recall found
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- All Lots within expiry/UDI: 00630414611099
- Quantity
- 7018 units
- 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.¿
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-06
Source: openFDA enforcement record Z-2890-2026 · search recall number Z-2890-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.