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	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).Section e1 - phone number complete information: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.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 a 3-year-old female patient.The following results were provided: (customer provided reference range: 0.7 - 1.48 ng/dl).(b)(6) 2026 sid (b)(6) initial result = 1.60 ng/dl, repeat result = 1.05 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a search for similar complaints, a ticket trending review, a device history record review, a labeling review, and in-house testing.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending data for the alinity i free t4 assay did identify an increase in complaints.Additionally, an increase in complaint activity was identified for reagent lot 78042ud00; however, in-house accuracy testing was completed with a retained kit of the complaint lot.Testing met acceptance criteria and the product is performing as expected.A review of the device history record did not identify any non-conformances, potential nonconformances, or deviations with lot number and the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 78042ud00.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 a 3-year-old female patient.The following results were provided: (customer provided reference range: 0.7 - 1.48 ng/dl) (b)(6) 2026, sid (b)(6), initial result = 1.60 ng/dl, repeat result = 1.05 ng/dl no impact to patient management was reported.

• 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: 24567732
• Report Number: 3005094123-2026-00119
• Device Sequence Number: 15595598
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260630(10)78042UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 04/16/2026

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: 06/30/2026
• Device Catalogue Number: 07P70-30
• Device Lot Number: 78042UD00
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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 Age: 3 YR
• Patient Sex: Female