FDA Adverse Event Malfunction Summary report: N

ALINITY I CMV IGG REAGENT KIT

MDR report key: 24765314 · Received April 2, 2026

Report

Report Number: 3008344661-2026-00064
Event Type: Malfunction
Date Received: April 2, 2026
Date of Event: March 17, 2026
Report Date: April 2, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: LFZ
UDI-DI: 00380740129798
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
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 7P42-24/-33, WITH 510K NUMBER K220949.

Description of Event or Problem · 0

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PREGNANT FEMALE PATIENT. THE RESULT WAS INCONSISTENT WITH THE PATIENT¿S PRIOR RESULTS. THE SAMPLE WAS RETESTED, WHICH YIELDED NONREACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). ON (B)(6) 2026 ALINITY I CMV IGG RESULT = 135 AU/ML ON (B)(6) 2026 REPEAT RESULTS = 0.0 AU/ML, 0.5 AU/ML, 0.4 AU/ML, 0.0 AU/ML ON (B)(6) 2025 SID (B)(6) RESULT: <6 AU/ML PER THE ALINITY CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
826279	ALINITY I CMV IGG REAGENT KIT	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	LFZ	ABBOTT IRELAND DIAGNOSTICS DIVISION		80613FZ00	00380740129798

Patients

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