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	01/27/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 result for one 75-year-old female patient.The sample was repeated with a lower results.The following data was provided: sid (b)(6): alinity serial number (b)(6) result = 27.48 pmol/l repeat result = 17.94 pmol/l.Alinity serial number (b)(6) result = 17.84 pmol/l.Alinity serial number (b)(6) result = 17.16 pmol/l.Reference range is 9-19 pmol/l no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional 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 82597ud00.However, testing was performed utilizing retained kits of lot 82597ud00 and noted that all testing passed, indicating the reagent lots are performing as expected.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint assay and complaint issue.Labeling was reviewed and found to adequately address the 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.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 assay, lot 82597ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 result for one 75-year-old female patient.The sample was repeated with a lower results.The following data was provided: sid(b)(6): alinity serial number (b)(6) result = 27.48 pmol/l repeat result = 17.94 pmol/l.Alinity serial number (b)(6) result = 17.84 pmol/l.Alinity serial number (b)(6) result = 17.16 pmol/l.Reference range is 9-19 pmol/l 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: 24316193
• Report Number: 3005094123-2026-00066
• Device Sequence Number: 17538764
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)261103(10)82597UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 04/21/2026

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 Catalogue Number: 07P70-30
• Device Lot Number: 82597UD00
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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 Age: 75 YR
• Patient Sex: Female