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	12/23/2025
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for two samples.The following data was provided: (b)(6) 2025 sample 1 sid (b)(6) initial result >64.350 pmol/l, repeated 10.341 and 12.188 pmol/l, tsh 0.845 miu/l serum lipaemic result 61.00 index (1+).Sample 2 sid (b)(6) initial result >64.350 pmol/l, repeated 49.596 / 55.342 / 43.883 pmol/l, tsh result <0.008 miu/l serum hemolyse result 166 index (2+).No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i free t4 reagent, lot 76559ud00 to address the customer¿s observation of falsely elevated results.A review of tracking and trending identified an increase in complaints for the alinity i free t4 reagent as well as an increase in complaint activity for lot 76559ud00.However, testing was performed utilizing retained kits of lot 76559ud00 and noted that all testing passed, indicating the reagent lots are performing as expected.A review in the corrective and preventive actions (capa) system did not identify any nonconformances, potential nonconformance or deviations associated with the complaint assay.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency with the alinity i free t4 reagent for lot 76559ud00 was identified.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for two samples.The following data was provided: (b)(6) 2025 sample 1 sid (b)(6) initial result >64.350 pmol/l, repeated 10.341 and 12.188 pmol/l, tsh 0.845 miu/l serum lipaemic result 61.00 index (1+).Sample 2 sid (b)(6) initial result >64.350 pmol/l, repeated 49.596 / 55.342 / 43.883 pmol/l, tsh result <0.008 miu/l serum hemolyse result 166 index (2+).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: 23888423
• Report Number: 3005094123-2025-00665
• Device Sequence Number: 4671495
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260512(10)76559UD00
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 03/31/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/31/2026
• 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