FDA Adverse Event Malfunction Summary report: N

ALINITY I FREE T4 REAGENT KIT

MDR report key: 24565483 · Received March 10, 2026

Report

Report Number: 3005094123-2026-00118
Event Type: Malfunction
Date Received: March 10, 2026
Date of Event: March 2, 2026
Report Date: May 21, 2026
Manufacturer: ABBOTT IRELAND DIAGNOSTICS DIVISION
Product Code: CEC
UDI-DI: 00380740173715
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. COMPLETE ENTRY SECTION E1 - ADDRESS 1 = (B)(6). 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 07P70, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122.

Description of Event or Problem · 0

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR 3 PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) 30-YEAR-OLD FEMALE PATIENT ALINITY INITIAL FT4 RESULT = 27.01 REPEAT RESULT = 13.45. SID (B)(6) 43-YEAR-OLD FEMALE PATIENT ALINITY INITIAL FT4 RESULT = 38.6 REPEAT RESULT = 13.51. SID (B)(6) 55-YEAR-OLD MALE PATIENT ALINITY INITIAL FT4 RESULT = 27.01 REPEAT RESULT = 17.01. REFERENCE RANGE IS 9.01-19.05 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
476250	ALINITY I FREE T4 REAGENT KIT	RADIOIMMUNOASSAY, FREE THYROXINE	CEC	ABBOTT IRELAND DIAGNOSTICS DIVISION		79271UD01	00380740173715

Patients

Seq	Age	Sex	Outcome	Treatment
1