Quick Facts at a Glance
- Recall Date
- January 20, 2026
- Hazard Level
- HIGH
- Brand
- Siemens Healthcare Diagnostics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Siemens Healthcare Diagnostics
- Product type
- Urine Albumin (UAlb) Assay
- Model numbers
- Material Number: 11537225, UDI-DI: 00630414611099, Lot Numbers: All lot numbers
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 20, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Siemens Healthcare Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Atellica CH Urine Albumin (UAlb) is used to measure urine albumin in patient samples as part of renal function assessment.
Why This Is Dangerous
Falsely depressed results for higher albumin concentrations may lead to incorrect clinical decisions.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Labs must halt using the affected material and follow recall procedures to protect patients.
Practical Guidance
How to identify if yours is affected
- Review Material Number 11537225.
- Note that all lot numbers are affected.
Where to find product info
Device labeling and the FDA recall page Z-1484-2026 for details.
What timeline to expect
Follow official recall instructions. Timeline for refunds or replacements is not specified.
If the manufacturer is unresponsive
- Escalate to risk management or biosafety if supplier is unresponsive.
- Document all communications and recall actions.
How to prevent similar issues
- Verify device and lot numbers before use.
- Implement recall management procedures in labs.
- Monitor FDA recall databases for updates.
Documentation advice
Keep recall notice, letters, lot numbers, and all correspondence with Siemens.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model/Material Number: 11537225. UDI-DI: 00630414611099. Lot numbers: All lot numbers. Quantity: 4,885 units. Sold worldwide, including US nationwide and the listed countries.
Key Facts
- All lot numbers affected
- Worldwide distribution including US and 30+ countries
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.