Atellica CH Urine Albumin recall
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Why was Atellica CH Urine Albumin recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
- Product
- Atellica CH Urine Albumin (UAlb). Material Number: 11537225
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4,885 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.
- Recall date
- March 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)