MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07P70-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated alinity i free t4 result for one patient.The following data was provided (customer¿s normal range is 10.8-20.2 pmol/l): sample id (b)(6) initial result was >64.35, repeat result was 15.9, repeat result, on another analyzer, was 17.3 pmol/l.Additional laboratory results were provided: tsh result was 3.03, repeat result was 3.02 uiu/ml.There was no impact to patient management reported.
Event or Problem Description
The customer observed a falsely elevated alinity i free t4 result for one patient.The following data was provided (customer¿s normal range is 10.8-20.2 pmol/l): sample id (b)(6) initial result was >64.35, repeat result was 15.9, repeat result, on another analyzer, was 17.3 pmol/l.Additional laboratory results were provided: tsh result was 3.03, repeat result was 3.02 uiu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated alinity i free t4 results included a search for similar complaints, the review of complaint text, trending data, labeling, device history records, and testing of retained reagent kit.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained reagent lot kit, stored at the recommended storage condition.Testing met acceptance criteria, and the products are performing as expected.Review of tracking and trending data identified an increase in complaints for the alinity i free t4 assay as well as an increase in complaint activity for reagent lot 76559ud00.However, testing was performed utilizing a retained kit of lot 76559ud00 and noted that all testing passed, indicating the reagent lot is performing as expected.Device history record review did not identify any non-conformances or deviations for the lot and complaint issue.Manufacturing documentation for the lot was reviewed and did not identify any issues.Labeling was reviewed and found to adequately address the issue under review.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i free t4, lot number 76559ud00, was identified.

• Brand Name: ALINITY I FREE T4 REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24180121
• Report Number: 3005094123-2026-00040
• Device Sequence Number: 21336300
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260512(10)76559UD00
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2026
• Device Catalogue Number: 07P70-30
• Device Lot Number: 76559UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown