Alinity i HBsAg Qualitative II Reagent Kit
Received Jul 28, 2026 · Event occurred Jul 15, 2026
Report 3008344661-2026-00108 · MDR key 50058103
Device
Generic name
Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
08P10-22
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A literature review article by Abu Sini, H., Shirron, et al. Clinical Impact of Routine HBV Screening in Oncologic Patients Prior to Chemotherapy. Journal of Clinical Medicine. 2026; 15(7), performed a study that generated false nonreactive Alinity i HBsAg Qualitative II for 4 patients when compared to positive HBV DNA PCR results tested on the Xpert HBV Viral Load Cepheid. These patients also had positive Anti-HBc results that correlated with the PCR testing. There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.Section A Patient Information: Refer to Section B5 for complete patient information. All available patient information was included. Additional patient details are not available.This report is being filed on an international product, list number 08P10-22 that has a similar product distributed in the US, list number 08P10-21/-31, with PMA number P110029.