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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one patient.The sample was frozen between each measurement.The following data was provided (reference range 12-22 pmol/l): first sample (the patient is positive for rheumatoid factor (rf)), sid 1, initial free t4 result 35.3 pmol/l ((b)(6) 2025), repeated 18.1 ((b)(6) 2025), 23.2 pmol/l ((b)(6) 2025), and 26.9 pmol/l ((b)(6) 2025).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.All available patient information was provided, no additional patient information was available.
Additional Manufacturer Narrative
Review of tracking and trending data identified an increase in complaints for the alinity i free t4 reagent as well as an increase in complaint activity for reagent lot 78042ud00.In-house testing was performed utilizing retained kits of lot 78042ud00.All validity and acceptance criteria were met, indicating that the product is performing as expected.A review in the corrective and preventive actions system did not identify any nonconformances or deviations associated with the complaint lot number and issue.Review of product labeling concluded the current issue is adequately addressed.Based on the investigation the alinity i free t4 reagent lot 78042ud00 is performing as intended, no systemic issue or deficiency of the alinity i free t4 reagent was identified.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one patient.The sample was frozen between each measurement.The following data was provided (reference range 12-22 pmol/l): first sample (the patient is positive for rheumatoid factor (rf)), sid (b)(6), initial free t4 result 35.3 pmol/l ((b)(6) 2025), repeated 18.1 ((b)(6) 2025), 23.2 pmol/l ((b)(6) 2025), and 26.9 pmol/l ((b)(6) 2025).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: 24220469
• Report Number: 3005094123-2026-00049
• Device Sequence Number: 9365921
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260630(10)78042UD00
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 01/30/2026
• 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 Sex: Unknown