MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA CH URINE ALBUMIN (UALB); ALBUMIN, ANTIGEN, ANTISERUM, CONTROL

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed urine albumin (ualb) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens healthineers has confirmed a potential for falsely depressed results for a small subset of samples above the measuring interval when using the atellica ch urine albumin (ualb) assay on the atellica ch and atellica ci analyzers.Us customers were notified through an urgent medical device correction (umdc, letter achc26-03.A.Us) and ous customers were identified through urgent field safety notice (ufsn, letter achc26-03.A.Ous) titled ¿atellica ch urine albumin (ualb) ¿ potential for falsely depressed results¿.The communication was directed to all customers who received atellica ch urine albumin (ualb) impacted lots informing them of the issue and providing instructions the customer must follow.
Event or Problem Description
The customer reported to siemens an erroneously depressed urine albumin (ualb) result was obtained on a patient sample on an atellica ch 930 analyzer.The erroneous result was not reported to the physician.The sample was reprocessed manually diluted (1:5) and auto diluted (1:10) on the same atellica ch 930 analyzer.Higher results were obtained, considered correct and one result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to erroneously depressed urine albumin (ualb) result.

• Brand Name: ATELLICA CH URINE ALBUMIN (UALB)
• Common Device Name: ALBUMIN, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 24245407
• Report Number: 2432235-2026-00020
• Device Sequence Number: 18201156
• Product Code: DCF
• UDI-Device Identifier: 00630414611099
• UDI-Public: (01)00630414611099(17)150528(17)261103
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11537225
• Device Lot Number: 150528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-01/29/2026-001-C
• Patient Sequence Number: 1
• Patient Sex: Female