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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity i free t4 results generated for patient samples.The following data was provided (customer¿s reference range 0.75-1.22 ng/dl): sample id (b)(6), (41-year-old female) initial result = 0.69 ng/dl, repeat = 0.84 ng/dl.Sample id (b)(6), (39-year-old female) initial result = 0.68 ng/dl, repeat = 0.76 ng/dl.Sample id (b)(6), (36-year-old female) initial result = 0.70 ng/dl, repeat = 0.79 ng/dl.Sample id (b)(6), (b)(6) initial result = 0.74 ng/dl, repeat = 0.88 ng/dl.Sample id (b)(6), (62-year-old female) initial result = 0.73 ng/dl, repeat = 0.87 ng/dl.Sample id (b)(6), (50-year-old female) initial result = 0.67 ng/dl, repeat = 0.76 ng/dl.Sample id (b)(6), (45-year-old female) initial result = 0.73 ng/dl, repeat = 0.84 ng/dl.Sample id (b)(6), (20-year-old female) initial result = 0.66 ng/dl, repeat = 0.75 ng/dl.No impact to patient management was reported.
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.This report is being filed on an international product, list number (b)(4), that has a similar product distributed in the us with the same list number, and a 510k/pma/bla number of k173122.

• 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 ; +49()6122582960
• MDR Report Key: 50275427
• Report Number: 3005094123-2026-00399
• Device Sequence Number: 10366755
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)270112(10)83268UD00
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/20/2026

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: 83268UD00
• 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: 07/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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).
• Patient Sex: Unknown