Atellica CH Urine Albumin (UAlb). Material Number: 11537225 recallZ-1484-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 20, 2026
Class II Open, Classified All recalls posted in March 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Siemens Healthineers notified consignees on about 01/20/2026 via mailed FedEx letter titled Urgent Medical Device Correction. Consignees were informed that as temporary mitigation, for any sample with a UAlb result above 5.0 mg/dL (50 mg/L), reanalyze the sample with a x10 dilution. If the diluted result is consistent with the initial result, either result may be reported. If the diluted result is inconsistent with the initial result, the diluted result should be reported. If you prefer to automate this dilution, please refer to your internal laboratory procedures. Consignees were instructed to review the notification with their Medical Director to determine the appropriate course of action, including evaluation of any previously generated results, if applicable, and complete and return the provided Field Correction Effectiveness Check Form. A follow-up communication will be provided when Customer Actions are no longer required.
Recall details
- Recall number
- Z-1484-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jan 20, 2026
- Posted by the FDA
- Mar 2, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 4,885 units
- Product code
- JIR
- 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.
Product description
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Code information (models, lots, serial numbers)
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Atellica CH Urine Albumin (UAlb) 11537225Siemens Healthcare Diagnostics Inc. · ALBUMIN, ANTIGEN, ANTISERUM, CONTROL2 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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