Class 2 Device Recall Atellica CH Urine Albumin

• Date Initiated by Firm: July 06, 2026
• Date Posted: August 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2890-2026
• Recall Event ID: 99389
• Product Classification: Indicator method, protein or albumin (urinary, non-quant.) - Product Code JIR
• Product: Atellica CH Urine Albumin REF: 11537225
• Code Information: All Lots within expiry/UDI: 00630414611099
• FEI Number: 2432235
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Customer Care; 914-631-8000
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 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, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Cura¿ao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel,¿Italy,¿Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic of Korea, Romania, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.¿
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.