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	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final 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 generated on the alinity i processing modules for one patient which was not reported to medical provider.The following data provided.(b)(6) male, sid (b)(6) , initial result 27.6 pmol/l, repeat result =17.4 pmol/l on (b)(6).The customer reference range: 9.0 to 19.0 pmol/l.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results generated on the alinity i processing modules for one patient which was not reported to medical provider.The following data provided.(b)(6) male, sid (b)(6), initial result 27.6 pmol/l, repeat result =17.4 pmol/l on (b)(6).The customer reference range: 9.0 to 19.0 pmol/l.There was no impact to patient management 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 did identify an increase in complaints for the alinity i free t4 assay (list number 07p70), however, no trends were identified for lot 78124ud00.The overall performance of the alinity i free t4 reagents in the field was reviewed using worldwide data.The review shows that the result for the median population for lot number 78124ud00 is within established limits, indicating the reagent lot is performing acceptably on market.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 78124ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 78124ud00.

• 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: 24344769
• Report Number: 3005094123-2026-00073
• Device Sequence Number: 9836226
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260710(10)78124UD00
• 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): 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): 04/10/2026

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: 07/10/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 78124UD00
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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: Male