FDA Adverse Event Malfunction Summary report: N

ALINITY I ANTI-HBS REAGENT KIT

MDR report key: 24570257 · Received March 11, 2026

Report

Report Number: 3008344661-2026-00052
Event Type: Malfunction
Date Received: March 11, 2026
Date of Event: March 2, 2026
Report Date: May 11, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LOM
UDI-DI: 00380740159900
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
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 INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88, WITH 510K/PMA/BLA NUMBER P050051.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I ANTI-HBS RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PATIENT. THE RESULT WAS NOT CONSISTENT WITH THE AUTOBIO PLATFORM. THE FOLLOWING DATA WAS PROVIDED: ALINITY I ANTI-HBS RESULT = 32.48 MIU/ML. AUTOBIO PLATFORM RESULT = NEGATIVE. PER THE ALINITY I ANTI-HBS PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
464530	ALINITY I ANTI-HBS REAGENT KIT	TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)	LOM	ABBOTT IRELAND DIAGNOSTICS DIVISION		73442FZ01	00380740159900

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		ALNTY I PR MOD CN, 03R65-20, (B)(6)