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	10/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reports discordant reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot 176 results on a patient sample relative to alternate method testing.The initial discordant result was reported to the patient.The patient was known to be negative in 2024; therefore, the sample was retested by the customer and result was positive.Sample was also sent to 2 other labs, and the results were negative and believed to be correct.The negative result was reported.There are no allegations of patient or user intervention or adverse health consequences due to the event.Quality control (qc) results were within acceptable ranges at the time of testing.For troubleshooting, an historical sample that resulted negative on atellica im on (b)(6) 2025 was retested at the customer site with lot 176 and resulted positive.Sample was also tested at another lab with lot 177 and was negative.Siemens is investigating.Note: per section g3 / g4, pma/510(k)number = p100039-s005_p100039-s016.
Event or Problem Description
The customer reports discordant reactive (positive) atellica im anti-hepatitis b surface antigen 2 (ahbs2) lot 176 results on a patient sample relative to alternate method testing.The initial discordant result was reported to the patient.The patient was known to be negative in 2024, therefore the sample was retested by the customer and result was positive.Sample was also sent to 2 other labs, and the results were negative and believed to be correct.The negative result was reported.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: 23560686
• Report Number: 1219913-2025-00208
• Device Sequence Number: 10081718
• 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): 05/19/2026

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: 11/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 05/19/2026
• 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: 20 YR
• Patient Sex: Female