Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin REF: 11537225

Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

On July 6, 2026, Siemens Healthineers issued a Urgent Medical Device Recall to affected consignees via Fed Ex. Siemens Healthineers ask consignees to take the following actions: 1. Discontinue Atellica CH Urine Albumin (UAlb) testing and transition to the Atellica CH Microalbumin_2 (ALB_2) reagent, SMN 11097610, and Atellica CH Microalbumin_2 Calibrator (ALB_2 CAL), SMN 11099435, as an alternate test solution. 2. Replace all reaction cuvette segments following discontinuation of UAlb testing. Refer to the Atellica Solution Online Help for instructions on replacing reaction cuvette segments. 3. Complete the Field Correction Effectiveness Check Form attached to this letter and return within 30 days. 4.Credit will be issued for unexpired UAlb reagent (SMN 11537225), UAlb calibrator (SMN 11537247), and reaction cuvettes segments, as applicable. 5. Please review this letter with your Medical Director to determine the appropriate course of action, including whether review of any previously generated results is warranted. 6. Please retain this letter with your laboratory records and forward this letter to those who may have received the affected product.

• FDA enforcement recordOfficial FDA database entry for Z-2890-2026
• FDA device classification · JIROfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1645The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.