Atellica CH Urine Albumin REF: 11537225

FDA device recall Z-2890-2026 · posted 2026-08-05 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica 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; and Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JIR

Quantity affected

7018 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH

Date initiated

2026-07-06

Date posted

2026-08-05

Location

Tarrytown, NY