MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number	04P53-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information provided on 05jan2026: sid: (b)(6): 49yrs old male: initial=1.44 s/co /repeated=1.50 and 1.49 s/co /repeated with lot number: 81084fz00=1.75, 1.43 and 1.38 s/co; neutralization test: c2=1.39 s/co and % neutralization=101.7%.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false repeat reactive architect hbsag qualitative results which questioned by the physician for several patients.The one result example provided were: initial=1.23 s/co (> or =1.00 s/co=reactive) /repeated after redrawn multiple times same patient=1.6, 1.7 and 1.33 s/co.Hbsag qual confirmatory c2=1.55 s/co; % neutralization=99% (c2=> or =0.70 s/co and % neutralization=> or =50%=confirmed positive).Additional information provided: all other hepatitis b markers are negative (no actual results provided).Additional information provided on 05jan2026: sid: (b)(6): 49yrs old male: initial=1.44 s/co /repeated=1.50 and 1.49 s/co /repeated with lot number: 81084fz00=1.75, 1.43 and 1.38 s/co; neutralization test: c2=1.39 s/co and % neutralization=101.7% there was no reported impact to patient management.
Additional Manufacturer Narrative
Updated section b3 date of event: additional information provided on 05jan2026 with new lot number 81084fz00.The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review for architect hbsag qualitative reagent, lot 81084fz00.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the architect hbsag qualitative assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 81084fz00.Device history record review did not identify any non-conformances or deviations with the complaint lots and complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.There was no issue with reagent performance identified.Based on the investigation, the device met performance specification and performed as intended at the customer site, therefore there is no systemic issue or deficiency with the architect hbsag qualitative reagent, lot 81084fz00.

• Brand Name: ARCHITECT HBSAG QUALITATIVE
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24059731
• Report Number: 3008344661-2026-00007
• Device Sequence Number: 9421229
• Product Code: LOM
• UDI-Device Identifier: 00380740007775
• UDI-Public: (01)00380740007775(17)260515(10)81084FZ00
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 05/15/2026
• Device Catalogue Number: 04P53-25
• Device Lot Number: 81084FZ00
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Age: 49 YR
• Patient Sex: Male