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	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one 63-year-old female, hospitalized for ileus.The following data was provided: 12dec2025 sid (b)(6) >5.0 ng/dl, repeated >5 ng/dl; serum sample 1.01 ng/dl, 17dec2025 sid (b)(6) >5.0 ng/dl, repeated 2.08 / 1.01 / 1.18 / 1.27 / 2.84 / 2.81 ng/dl; serum sample 2.08 ng/dl; tsh 1.71 uiu/ml, free t3 2.78 pg/ml.Historical results: 31oct2025 free t4 result 1.15 ng/dl.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 results for one 63-year-old female, hospitalized for ileus.The following data was provided: (b)(6) 2025 sid (b)(6) >5.0 ng/dl, repeated >5 ng/dl; serum sample 1.01 ng/dl, (b)(6) 2025 sid (b)(6) >5.0 ng/dl, repeated 2.08 / 1.01 / 1.18 / 1.27 / 2.84 / 2.81 ng/dl; serum sample 2.08 ng/dl; tsh 1.71 uiu/ml, free t3 2.78 pg/ml.Historical results: 31oct2025 free t4 result 1.15 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did not identify an increase in complaint activity for lot 75641d00.A review of tracking and trending data for the alinity i free t4 assay did identify an increase in complaints; however, in-house performance testing was performed utilizing retained reagent kit of the complaint lot.All testing passed, indicating the reagent lot is performing as expected.A review of the device history record did not identify any non-conformances, potential nonconformances or deviations associated with lot number 75641ud00 and the complaint issue.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 75641ud00.A.

• 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: 23979320
• Report Number: 3005094123-2026-00006
• Device Sequence Number: 18793951
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260421(10)75641UD00
• 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): 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): 03/24/2026

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: 04/21/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 75641UD00
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: 63 YR
• Patient Sex: Female