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	01/03/2026
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.A1 - patient identifier: (b)(6) (complete sample id exceeded characters allowed in this field).
Event or Problem Description
The customer reported falsely elevated alinity i free t4 and provided the following data for sample id (b)(6): on 3 jan the result was 1.33 ng/dl on 5 jan, the result was 1.75 ng/dl on 6 jan the results were 1.12 ng/dl & 1.10 ng/dl customer reference range: 0.81 to 1.32 ng/dl patient information: 16-year-old female.There was no reported impact to patient management.
Additional Manufacturer Narrative
Section a patient information and section b5 have been updated with additional data.Concomitant products updated with additional information.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported falsely elevated alinity i free t4 and provided the following data for sample id (b)(6): on (b)(6) the result was 1.33 ng/dl, on (b)(6), the result was 1.75 ng/dl, on (b)(6) the results were 1.12 ng/dl & 1.10 ng/dl, customer reference range: 0.81 to 1.32 ng/dl.Patient information: 16 year old female.There was no reported impact to patient management.Update: the customer reported more patients with falsely elevated alinity i free t4 and provided the following data: sample id (b)(6) (male, 47 years old): on (b)(6) results were 1.09 ng/dl (from sn: (b)(6)) and 2.28 ng/dl (from sn: (b)(6)), on (b)(6) results were 1.05 ng/dl (from sn: (b)(6)) and 1.03 ng/dl (from sn: (b)(6)).Sample id (b)(6) (female, 37 years old) on (b)(6) results were 1.14 ng/dl (from sn: (b)(6)) and 1.42 ng/dl (from sn: (b)(6)), on (b)(6) results were 1.08 ng/dl (from sn: (b)(6)) and 1.09 ng/dl (from sn: (b)(6)).Sample id (b)(6) (gender and age not provided): on (b)(6) the result was 4.06 ng/dl (from sn: (b)(6)).On (b)(6) the results were 1.69 ng/dl (from sn: (b)(6)), 0.97 ng/dl (from sn: (b)(6)), 1.29 ng/dl (from sn: (b)(6)), 1.82 ng/dl (from sn: (b)(6)) & 0.96 ng/dl (from sn: (b)(6)).The sample was tested further with siemens atellica and generated the results of 1.54 ng/dl & 1.31 ng/dl.Sample id (b)(6) (female, 61 years old) on (b)(6) the results were 3.16 ng/dl, 1.98 ng/dl, 1.89 ng/dl, 1.40 ng/dl, & 1.32 ng/dl (from sn (b)(6)).The sample was repeated on sn: (b)(6) and the results were 1.60 ng/dl, 1.70 ng/dl, 1.76 ng/dl, 1.17 ng/dl, & 1.22 ng/dl.Sample id (b)(6) (male, 73 years old): on (b)(6) the result was 1.99 ng/dl (from sn (b)(6)).On (b)(6) the sample was repeated and generated the following results of 1.05 ng/dl (from sn: (b)(6)), 1.09 ng/dl (from sn: (b)(6)), 1.06 ng/dl and 1.05 ng/dl (from sn: (b)(6)).
Event or Problem Description
The customer reported falsely elevated alinity i free t4 and provided the following data for sample id (b)(6): on (b)(6) the result was 1.33 ng/dl, on (b)(6), the result was 1.75 ng/dl, on (b)(6) the results were 1.12 ng/dl & 1.10 ng/dl, customer reference range: 0.81 to 1.32 ng/dl.Patient information: 16 year old female.There was no reported impact to patient management.Update: the customer reported more patients with falsely elevated alinity i free t4 and provided the following data: sample id (b)(6) (male, 47 years old): on (b)(6) results were 1.09 ng/dl (from sn: (b)(6)) and 2.28 ng/dl (from sn: (b)(6)) on (b)(6) results were 1.05 ng/dl (from sn: (b)(6)) and 1.03 ng/dl (from sn: (b)(6)).Sample id (b)(6) (female, 37 years old): on (b)(6) results were 1.14 ng/dl (from sn: (b)(6)) and 1.42 ng/dl (from sn: (b)(6)) on (b)(6) results were 1.08 ng/dl (from sn: (b)(6)) and 1.09 ng/dl (from sn: (b)(6)).Sample id (b)(6) (gender and age not provided): on (b)(6) the result was 4.06 ng/dl (from sn: (b)(6)).On (b)(6) the results were 1.69 ng/dl (from sn: (b)(6)), 0.97 ng/dl (from sn: (b)(6)), 1.29 ng/dl (from sn: (b)(6)), 1.82 ng/dl (from sn: (b)(6)) & 0.96 ng/dl (from sn: (b)(6)).The sample was tested further with siemens atellica and generated the results of 1.54 ng/dl & 1.31 ng/dl.Sample id (b)(6) (female, 61 years old): on (b)(6) the results were 3.16 ng/dl, 1.98 ng/dl, 1.89 ng/dl, 1.40 ng/dl, & 1.32 ng/dl (from sn (b)(6)).The sample was repeated on sn: (b)(6) and the results were 1.60 ng/dl, 1.70 ng/dl, 1.76 ng/dl, 1.17 ng/dl, & 1.22 ng/dl.Sample id (b)(6) (male, 73 years old): on (b)(6) the result was 1.99 ng/dl (from sn (b)(6)).On (b)(6) the sample was repeated and generated the following results of 1.05 ng/dl (from sn: (b)(6)), 1.09 ng/dl (from sn: (b)(6)), 1.06 ng/dl and 1.05 ng/dl (from sn: (b)(6)).
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending data identified an increase in complaints for the alinity i free t4 assay as well as an increase in complaint activity for reagent lot 76559ud00.However, accuracy testing was performed utilizing retained kits of lot 76559ud00 and noted that all testing passed, indicating the reagent lot is performing as expected.Device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 76559ud00 and the complaint issue.Per the limitations of the procedure section of the package insert, results should be used in conjunction with other data, e.G., symptoms, results of other thyroid tests, clinical impressions, etc.If the free t4 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.Details around reagent and specimen handling are outlined in the product package insert, while the alinity i system operations manual also provides information regarding further potential causes of elevated results.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 reagent, lot 76559ud00 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 ; 6122582960
• MDR Report Key: 24192490
• Report Number: 3005094123-2026-00041
• Device Sequence Number: 21210795
• 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,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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 03/25/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/19/2026; 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 16 YR
• Patient Sex: Female