Z-2890-2026Class II

Atellica CH Urine Albumin REF: 11537225

Name: Z-2890-2026 Atellica CH Urine Albumin REF: 11537225
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-07-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2026-07-06 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Urine Albumin REF: 11537225 on 2026-07-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2890-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-06
Posted: 2026-08-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Urine Albumin REF: 11537225
Product code: JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
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 root 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.¿
Product codes and lots: All Lots within expiry/UDI: 00630414611099

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2890-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2890-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code JIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)