FDA Adverse Event Malfunction Summary report: N

ALINITY I CMV IGG REAGENT KIT

MDR report key: 25073028 · Received May 4, 2026

Report

Report Number: 3008344661-2026-00070
Event Type: Malfunction
Date Received: May 4, 2026
Date of Event: April 11, 2026
Report Date: May 4, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LFZ
UDI-DI: 00380740129798
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24, AND A 510K NUMBER OF K220949.

Description of Event or Problem · 0

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR A 30-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<6.0 AU/ML IS NONREACTIVE, >/=6.0 AU/ML IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON 11APR2026, WAS 28.5 AU/ML. A DIFFERENT SAMPLE FROM THE PATIENT WAS TESTED ON 15APR2026 AND THE RESULT WAS 30.25 AU/ML. THE PATIENT SAMPLE WAS TESTED AT OTHER LABORATORIES USING ROCHE ASSAYS AND THE RESULTS WERE: LABORATORY 1: IGG <0.25 U/ML; IGM = 0.22 (THRESHOLD < 0.7); LABORATORY 2: IGG <0.25 U/ML; IGM = 0.17. THE AVIDITY RESULT, TESTED USING A DIASORIN LIAISON ASSAY, WAS <0.150, WHICH IS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
404697	ALINITY I CMV IGG REAGENT KIT	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	LFZ	ABBOTT IRELAND DIAGNOSTICS DIVISION		83053FZ00	00380740129798

Patients

Seq	Age	Sex	Outcome	Treatment
1	30 YR	Female		ALNTY I PROCESSING MODU, 03R65-01, (B)(6).