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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: the customer does not have further information about the patient.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false elevated alinity i free t4 results.Sid (b)(6) generated 5 ng/dl, repeated 1.26 ng/dl, repeated 1.98 ng/dl, repeated 0.99 ng/dl.Normal range 0.7-1.48 ng/dl.The customer does not have further information about the patient.No impact to patient management was reported.
Event or Problem Description
The customer observed false elevated alinity i free t4 results.Sid (b)(6) generated >5 ng/dl, repeated 1.26 ng/dl, repeated 1.98 ng/dl, repeated 0.99 ng/dl.Normal range 0.7-1.48 ng/dl.The customer does not have further information about the patient.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A 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 71236ud00.However, testing performed using retained kits from lot 71236ud00 showed that all results passed, indicating the reagent lot is performing as expected.A device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the complaint lot or issue.Labeling was reviewed and found to adequately address the current issue.Based on the investigation, no systemic issue or deficiency with the alinity i free t4 assay, lot 71236ud00 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: 23173337
• Report Number: 3005094123-2025-00485
• Device Sequence Number: 15862799
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)251125(10)71236UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 11/25/2025
• Device Catalogue Number: 07P70-20
• Device Lot Number: 71236UD00
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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