MAUDE Adverse Event Report: Siemens Healthcare Diagnostics, Inc. Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer alleges an atellica im atellica im anti-hepatitis b surface antigen 2 (ahbs2) discordant positive (reactive) result for a patient compared to negative hepatitis b serology results tested in another laboratory on an alternate method.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Event or Problem Description
The customer alleges an atellica im atellica im anti-hepatitis b surface antigen 2 (ahbs2) discordant positive (reactive) result for a patient compared to negative hepatitis b serology results tested in another laboratory on an alternate method.There are no allegations of patient or user intervention or adverse health consequences due to the event.

• Brand Name: Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)
• Common Device Name: Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
• Manufacturer (Section D): Siemens Healthcare Diagnostics, Inc.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): Siemens Healthcare Diagnostics, Inc.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 50515062
• Report Number: 1219913-2026-00171
• Device Sequence Number: 18469022
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)31535179(17)271017
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P100039-S016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 10995453
• Device Lot Number: 31535179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 10/17/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown