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

FDA device recall Z-1484-2026 · posted 2026-03-02 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JIR

Quantity affected

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, I

Date initiated

2026-01-20

Date posted

2026-03-02

Location

Tarrytown, NY