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	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information (26-mar-2026): 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.Section h6 has been updated to reflect the investigation.Initial mdr 2432235-2026-00058 was filed on 19-feb-2026.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed urine albumin (ualb) patient sample result on an atellica ch 930 analyzer.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported to siemens that after processing a patient sample for urine albumin (ualb) on a atellica ch 930 analyzer, previous results for the same patient were questioned.The customer believes the results obtained on the patient sample from (b)(6) 2026 to be correct.There are no known reports of patient intervention or adverse health consequences due to the discordant urine albumin (ualb) results.

• 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: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 9173315804
• MDR Report Key: 24392920
• Report Number: 2432235-2026-00058
• Device Sequence Number: 16078228
• Product Code: DCF
• UDI-Device Identifier: 00630414611099
• UDI-Public: (01)00630414611099(10)150456(17)260922
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Expiration Date: 09/22/2026
• Device Model Number: N/A
• Device Catalogue Number: 11537225
• Device Lot Number: 150456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2025
• 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: Unknown