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	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an erroneous atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to repeat testing.The initial result for this patient (tested (b)(6) 2025) was strongly reactive.When a new sample was drawn and tested in (b)(6), a nonreactive result was obtained.This was reproduced in repeat testing of this sample, and the nonreactive result was accepted as correct.When the original sample (from (b)(6) was re-tested to investigate, it again produced a very strongly reactive result.There are no allegations of any adverse patient consequences in association with the observed discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an erroneous atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to repeat testing.Siemens is investigating.Note: for section g3 / g4, pma/510(k) number = p100039-s005_p100039-s016.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a false positive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result which was discordant relative to repeat testing.Update, 27-jan-2025: siemens has concluded the investigation.The customer reported multiple observations of discordance involving multiple ahbs2 product lots.[other events reported separately to fda.] siemens investigation included a comprehensive review of reagent and instrument performance.Reagent-related issues were ruled out on the basis of demonstrated quality control (qc) and a review of current assay performance.No issues were identified with qc or other patient samples in the timeframe of the reported discordance.Testing for potential interferents, including heterophilic antibodies (hbt or nabt), was not performed by the customer.The original patient samples were not available for testing by siemens, and the customer declined to provide additional clinical or analytical information.As a result, siemens was unable to perform additional investigative testing.Based on the available information, a specific cause for the observed discordance could not be determined.The customer is operational, and no evidence of a systemic reagent- or instrument-related issue was identified.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• 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: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 23956854
• Report Number: 1219913-2026-00004
• Device Sequence Number: 18501097
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: (01)00630414597836(10)05988176(17)270130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: SEE H10.
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 05988176
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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 Age: 26 YR
• Patient Sex: Male