—#218477

Product

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

FDA product code: JIR — Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2026-01-20
Posted by FDA: 2026-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.