Z-1484-2026Class II

Atellica CH Urine Albumin (UAlb). Material Number: 11537225

Name: Z-1484-2026 Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-01-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-01-20 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Urine Albumin (UAlb). Material Number: 11537225 on 2026-01-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1484-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-20
Posted: 2026-03-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Product code: JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1484-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1484-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-11	2026-03-02

Product code JIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)