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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results for multiple patients.The following data were provided: sid (b)(6)(female, born 1947) (7sep2026) initial: >64.35 pmol/l, repeat: 19.13 pmol/l, 17.70 pmol/l.Sid (b)(6)(male, born 1979) ((b)(6) 2026) initial: >64.35 pmol/l.Repeat: 15.31 pmol/l.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 results for multiple patients.The following data were provided: sid (b)(6) (female, born 1947) (b)(6) 2026) initial: >64.35 pmol/l repeat: 19.13 pmol/l, 17.70 pmol/l.Sid (b)(4) (male, born 1979) (b)(6) 2026) initial: >64.35 pmol/l repeat: 15.31 pmol/l.No impact to patient management was reported.
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.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending identified an increase in complaint activity for the alinity i free t4; however, no trends were identified for lot 87264ud00.A labeling review concludes that the complaint issue is adequately addressed.A device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot 87264ud00 and the complaint issue.Customer field data was used to assess the performance of the alinity i free t4 using worldwide data.The median patient result for the complaint lot is within the established limits, indicating that the reagent lot is performing acceptably in the field.Based on our investigation, no systemic issue or deficiency of the alinity i free t4 lot 87264ud00 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 ; +49()6122582960
• MDR Report Key: 50846171
• Report Number: 3005094123-2026-00477
• Device Sequence Number: 10269849
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 09/21/2026

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: 87264UD00
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2026
• 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).; ALNTY I PROCESSING MODU, 03R65-01, AI04434
• Patient Sex: Unknown