MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Products, Limited Atellica IM HBc Total 2 (HBcT2); Qualitative and Quantitative Hepatitis B Virus Antibody Assays

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• Brand Name: Atellica IM HBc Total 2 (HBcT2)
• Common Device Name: Qualitative and Quantitative Hepatitis B Virus Antibody Assays
• Manufacturer (Section D): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer (Section G): Siemens Healthcare Diagnostics Products, Limited; glyn rhonwy, gwynedd; llanberis LL554 EL; UK LL554EL
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; +1(508)298-5306
• MDR Report Key: 50098683
• Report Number: 1219913-2026-00156
• Device Sequence Number: 21400358
• Product Code: SEI
• UDI-Device Identifier: 00630414604138
• UDI-Public: (01)00630414604138(10)08176017(17)270911
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210019
• 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,Followup
• Report Date (Section B): 08/18/2026

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: 11200739
• Device Lot Number: 08176017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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: 68 YR
• Patient Sex: Female