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	02/24/2026
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.All available patient information was included, no additional patient information was available.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 result generated by the alinity i processing module for a 75-year-old female patient.Upon repeat testing, the sample yielded a normal result.It was also noted that the patient¿s thyroid results have been within normal ranges for the past three years.The following data were provided: lab¿s normal range: 0.70 to 1.48 ng/dl.Sid (b)(6): (b)(6) 2026 initial alinity i free t4 result = >5.00 ng/dl repeat result on another instrument (b)(6) = 1.33 ng/dl 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 did identify an increase in complaints for list number 07p70, however, no trends were identified for lot complaint lot.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint assay and complaint issue.Review of instrument data reports shows that the median patient result for the master lot falls within +/-3sd of the established baseline, indicating the reagent lot is performing acceptably on market.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 80419ud00.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 result generated by the alinity i processing module for a 75-year-old female patient.Upon repeat testing, the sample yielded a normal result.It was also noted that the patient¿s thyroid results have been within normal ranges for the past three years.The following data were provided: lab¿s normal range: 0.70 to 1.48 ng/dl sid (b)(6): (b)(6) 2026 initial alinity i free t4 result = >5.00 ng/dl repeat result on another instrument (b)(6) = 1.33 ng/dl 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: 24604402
• Report Number: 3005094123-2026-00125
• Device Sequence Number: 18742527
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260919(10)80419UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Expiration Date: 09/19/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 80419UD00
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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 Age: 75 YR
• Patient Sex: Female