FDA Adverse Event Malfunction Summary report: N

ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT

MDR report key: 25260412 · Received May 22, 2026

Report

Report Number: 3008344661-2026-00075
Event Type: Malfunction
Date Received: May 22, 2026
Date of Event: May 14, 2026
Report Date: May 22, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LOM
UDI-DI: 00380740130466
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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 PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P11-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P11-21, WITH 510K/PMA/BLA NUMBER P110029.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I HBSAG QUALITATIVE II AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY RESULTS FOR A MALE PATIENT BETWEEN THE AGES OF 40-50 YEARS OLD. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) HBSAG INITIAL RESULT = 2.05 S/CO, REPEAT RESULT = 2.17 S/CO HBSAG CONFIRMATION RESULT = 102% NEUT, HBSAG QUAC2 = 2.03 S/CO, CONFIRMED POSITIVE. ADDITIONAL LAB RESULTS PROVIDED: ANTI-HBS DIL = 0.88 MIU/ML, ANTI-HBE = 1.85 S/CO NONREACTIVE, HBEAG = 0.319 S/CO NONREACTIVE, ANTI-HBC = 0.07 S/CO NONREACTIVE, ANTI-HBC M = 0.09 S/CO NONREACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
587799	ALINITY I HBSAG QUALITATIVE II CONFIRMATORY REAGENT KIT	TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)	LOM	ABBOTT IRELAND DIAGNOSTICS DIVISION		82455FZ00	00380740130466

Patients

Seq	Age	Sex	Outcome	Treatment
1