FDA Adverse Event Malfunction Summary report: N

ARCHITECT HBSAG QUALITATIVE II

MDR report key: 25316751 · Received May 28, 2026

Report

Report Number: 3008344661-2026-00078
Event Type: Malfunction
Date Received: May 28, 2026
Date of Event: January 1, 2025
Report Date: May 28, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LOM
UDI-DI: 00380740002435
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02G22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P54, WITH 510K/PMA/BLA NUMBER P110029. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem · 0

A LITERATURE STUDY BY DASDEMIR FO ET AL.,¿COMPARATIVE EVALUATION OF A NEW-GENERATION HBSAG ASSAY VERSUS A CONVENTIONAL METHOD IN OCCULT HBV INFECTION AND LOW-LEVEL HBSAG POSITIVITY,¿ MIKROBIYOLOJI BULTENI 2026;60 (2):177¿187, EVALUATED THE DIAGNOSTIC PERFORMANCE OF THE ABBOTT ARCHITECT HBSAG QUALITATIVE II ASSAY COMPARED WITH A NEXT-GENERATION ASSAY (ALINITY I HBSAG NEXT QUALITATIVE) IN DETECTING HEPATITIS B INFECTION. THE STUDY REPORTED FALSE NONREACTIVE ARCHITECT HBSAG QUALITATIVE II RESULTS FOR 100 OCCULT HEPATITIS B INFECTION (OBI) CASES, ALL OF WHICH WERE CONFIRMED TO BE HBV DNA POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
296566	ARCHITECT HBSAG QUALITATIVE II	TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)	LOM	ABBOTT IRELAND DIAGNOSTICS DIVISION			00380740002435

Patients

Seq	Age	Sex	Outcome	Treatment
1