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	12/19/2025
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.
Event or Problem Description
The customer observed elevated alinity i free t4 and provided the following data: on (b)(6) 2025, sample id (b)(6) result was > 64 (customer reference range 9-19 pmol/l).The customer reported that there was not enough sample to retest.The customer provided the following historical and additional thyroid test results: on (b)(6) 2024 (sample id (b)(6), free t4 was 15 pmol/l was and tsh was 3.42 mu/l, on (b)(6) 2025 (sample id (b)(6), free t4 was 15 pmol/l was and tsh was 3.40 mu/l, on (b)(6) 2024 (sample id (b)(6), free t4 was 14 pmol/l was and tsh was 5.68 mu/l, on (b)(6) 2025, sample id (b)(6), tsh was 1.29 mu/l.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Event or Problem Description
The customer observed elevated alinity i free t4 and provided the following data: on (b)(6) 2025, sample id (b)(6) result was 64 (customer reference range 9-19 pmol/l).The customer reported that there was not enough sample to retest.The customer provided the following historical and additional thyroid test results: on (b)(6) 2024 sample id (b)(6), free t4 was 15 pmol/l was and tsh was 3.42 mu/l.On (b)(6) 2025 sample id (b)(6), free t4 was 15 pmol/l was and tsh was 3.40 mu/l.On (b)(6) 2024 sample id (b)(6), free t4 was 14 pmol/l was and tsh was 5.68 mu/l.On (b)(6) 2025, sample id (b)(6) tsh was 1.29 mu/l.Per the customer discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.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 73465ud00.However, accuracy testing was performed utilizing retained kits of lot 73465ud00 and noted that all testing passed, indicating the reagent lot is performing as expected.Device history record review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot number and complaint issue.Per the limitations of the procedure section of the package insert, results should be used in conjunction with other data, e.G., symptoms, results of other thyroid tests, clinical impressions, etc.If the free t4 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Details around reagent and specimen handling are outlined in the product package insert, while the alinity i system operations manual also provides information regarding further potential causes of elevated results.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 reagent, lot 73465ud00 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: 24040641
• Report Number: 3005094123-2026-00016
• Device Sequence Number: 21101031
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260224(10)73465UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 02/24/2026
• Device Catalogue Number: 07P70-30
• Device Lot Number: 73465UD00
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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, AI01986; ALNTY I PROCESSING MODU, 03R65-01, AI01986
• Patient Sex: Unknown