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

Catalog Number	07P70-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one 76-year-old male patient.The following data was provided (reference range: 9 to 19 pmol/l): sid (b)(6).Initial alinity i free t4 result (b)(6) 2026 was 36.2239 pmol/l.Repeat measurements following physician complaint were 16.3527 pmol/l (2:06 pm) and 16.9720 pmol/l (2:45 pm).Other results provided: tsh level >0.01 no impact to patient management was reported.
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one 76-year-old male patient.The following data was provided (reference range: 9 to 19 pmol/l): sid (b)(6) initial alinity i free t4 result (b)(6) 2026 was 36.2239 pmol/l.Repeat measurements following physician complaint were 16.3527 pmol/l (2:06 pm) and 16.9720 pmol/l (2:45 pm).Other results provided: tsh level >0.01 no impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i free t4 reagent lot 82220ud00 to address the customer¿s observation of falsely elevated results.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.The overall performance of the alinity i free t4 reagents in the field was reviewed using worldwide field data.The review shows that the result for the median population is within established limits, indicating the reagent lot is performing acceptably on market.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent lot 82220ud00.

• 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: 24505251
• Report Number: 3005094123-2026-00104
• Device Sequence Number: 21361113
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)261201(10)82220UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/01/2026

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 Catalogue Number: 07P70-20
• Device Lot Number: 82220UD00
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2025
• 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 Age: 76 YR
• Patient Sex: Male