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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
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.Complete information from section a1 patient identifier: multiple = sid (b)(6).All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed erratic alinity i free t4 for multiple patients.The customer notes that the results were within normal range, but later the results were out of reference range.The following data was provided: reference ranges: adults: 0.75 to 1.22 ng/dl.Pediatrics: < 1 month not available.1 to 23 months: 0.86 to 1.32 ng/dl.2 to 12 years: 0.84 to 1.32 ng/dl.13 to 18 years: 0.81 to 1.32 ng/dl.Sid (b)(6), 9-year-old male, initial free t4 result= 1.30 ng/dl; repeat result= 1.93 ng/dl.Sid (b)(6), 39-year-old male, initial free t4 result= 1.06 ng/dl; repeat result= 1.30 ng/dl.Sid (b)(6), 73-year-old male, initial free t4 result= 1.32 ng/dl; repeat result= 1.55 ng/dl.Further testing of the samples was performed: sid (b)(6).(b)(6) 2025, analyzer (b)(6), free t4 result= 1.30 ng/dl.(b)(6) 2025, after homogenizing the sample, analyzer (b)(6), result= 1.93 ng/dl; analyzer (b)(6), result= 1.96 ng/dl, 1.88 ng/dl, 1.87 ng/dl.(b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.02 ng/dl; analyzer (b)(6) result= 1.06 ng/dl; (b)(6) 2025, analyzer (b)(6) result= 1.06 ng/dl.Sid (b)(6).(b)(6) 2025, analyzer (b)(6), free t4 result= 1.06 ng/dl.(b)(6) 2025, after homogenizing the sample, analyzer (b)(6) result= 1.30 ng/dl; analyzer (b)(6) result= 1.40 ng/dl, 1.34 ng/dl, 1.40 ng/dl.(b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.00 ng/dl, analyzer (b)(6) result= 1.12 ng/dl; (b)(6) 2025, analyzer (b)(6) result= 1.09 ng/dl.Sid (b)(6).(b)(6) 2025, analyzer (b)(6) free t4 result= 1.32 ng/dl.(b)(6) 2025, after homogenizing the sample; analyzer (b)(6) result= 1.55 ng/dl; analyzer (b)(6) result= 1.54 ng/dl, 1.56 ng/dl, 1.52 ng/dl.(b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.17 ng/dl; analyzer (b)(6) result= 1.22 ng/dl, (b)(6) 2025, analyzer (b)(6) result= 1.25 ng/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in house testing of a retained kit and labeling review.Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify an increase in complaints for list number 07p70, however, no trends were identified for lot 76559ud00.A device history record review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot number and complaint issue.In-house accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 reagent lot 76559ud00 was identified.
Event or Problem Description
The customer observed erratic alinity i free t4 for multiple patients.The customer notes that the results were within normal range, but later the results were out of reference range.The following data was provided: reference ranges: adults: 0.75 to 1.22 ng/dl.Pediatrics: < 1 month not available 1 to 23 months: 0.86 to 1.32 ng/dl.2 to 12 years: 0.84 to 1.32 ng/dl.13 to 18 years: 0.81 to 1.32 ng/dl.Sid (b)(6), 9-year-old male, initial free t4 result= 1.30 ng/dl; repeat result= 1.93 ng/dl.Sid (b)(6), 39-year-old male, initial free t4 result= 1.06 ng/dl; repeat result= 1.30 ng/dl.Sid (b)(6), 73-year-old male, initial free t4 result= 1.32 ng/dl; repeat result= 1.55 ng/dl.Further testing of the samples was performed: sid (b)(6) (b)(6) 2025, analyzer (b)(6), free t4 result= 1.30 ng/dl (b)(6) 2025, after homogenizing the sample, analyzer (b)(6), result= 1.93 ng/dl; analyzer (b)(6), result= 1.96 ng/dl, 1.88 ng/dl, 1.87 ng/dl (b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.02 ng/dl; analyzer (b)(6) result= 1.06 ng/dl; (b)(6) 2025, analyzer (b)(6) result= 1.06 ng/dl sid (b)(6) (b)(6) 2025, analyzer (b)(6), free t4 result= 1.06 ng/dl (b)(6) 2025, after homogenizing the sample, analyzer (b)(6) result= 1.30 ng/dl; analyzer (b)(6) result= 1.40 ng/dl, 1.34 ng/dl, 1.40 ng/dl (b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.00 ng/dl, analyzer (b)(6) result= 1.12 ng/dl; (b)(6) 2025, analyzer (b)(6) result= 1.09 ng/dl.Sid (b)(6) (b)(6) 2025, analyzer (b)(6) free t4 result= 1.32 ng/dl (b)(6) 2025, after homogenizing the sample; analyzer (b)(6) result= 1.55 ng/dl; analyzer (b)(6) result= 1.54 ng/dl, 1.56 ng/dl, 1.52 ng/dl (b)(6) 2025, after recentrifuging the sample, analyzer (b)(6) result= 1.17 ng/dl; analyzer (b)(6) 7 result= 1.22 ng/dl, (b)(6) 2025, analyzer (b)(6) result= 1.25 ng/dl.There was no impact to patient management 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: 24005213
• Report Number: 3005094123-2026-00009
• Device Sequence Number: 9405994
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260512(10)76559UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/31/2026

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: 05/12/2026
• Device Catalogue Number: 07P70-30
• Device Lot Number: 76559UD00
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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 Sex: Unknown