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	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed imprecision for the alinity free t4 assay.The customer has also confirmed that they are repeating all ft4s above or below the reference range where the tsh is within the reference range.Normal range of 9.01 to 19.05 pmol/l.The following data was provided: sid / date / time / results (b)(6) on (b)(6) 2026, 2:49:44 pm, exception, exception 8.4 9.9 (b)(6) on (b)(6) 2026, 2:30:38 pm, 8.2 8.2 9.3.(b)(6) on (b)(6) 2026, 4:22:39 pm, 8.3 8.3 9.3.(b)(6) on (b)(6) 2026, 10:50:56 am, 8.3 8.3 9.3.(b)(6) on (b)(6) 2026, 5:48:01 pm, 8.3 8.3 9.3.(b)(6) on (b)(6) 2026, 1:50:24 pm, 8.4 8.4 9.3.(b)(6) on (b)(6) 2026, 7:41:42 pm, 7.7 7.7 9.5.(b)(6) on (b)(6) 2026, 3:09:59 am 8.5 8.5 9.5.(b)6) on (b)(6) 2026, 6:40:48 pm, 8.6 8.6 9.6.(b)(6) on (b)(6) 2026, 3:54:37 pm, 8.6 8.6 9.8.(b)(6) on (b)(6) 2026, 6:12:00 pm, 8.6 8.6 9.8.(b)(6) on (b)(6) 2026, 7:20:45 pm, 8.7 8.7 9.8.(b)(6) on (b)(6) 2026, 7:03:01 pm, 8.9 8.9 9.8.(b)(6) on (b)(6) 2026, 2:58:48 pm, 8.9 8.9 9.8.(b)(6) on (b)(6) 2026 4:49:41 pm, 8.8 8.8 9.9.(b)(6) on (b)(6) 2026, 12:59:49 pm, 9 9 9.9.(b)(6) on (b)(6) 2026, 5:40:33 pm, 8.4 8.4 10.(b)(6) on (b)(6) 2026, 2:24:49 pm, 8.7 8.7 10.(b)(6) on(b)(6) 2026, 6:37:15 pm, 8.8 8.8 10.(b)(6) on (b)(6) 2026, 7:48:12 pm, 8 8 10.1.(b)(6) on (b)(6) 026, 3:37:59 pm, 8.6 8.6 10.1.(b)(6) on (b)(6) 2026, 5:53:24 pm, 8.7 8.7 10.2.(b)(6) on (b)(6) 2026, 5:50:42 pm, 8.8 8.8 10.2.(b)(6) on (b)(6) 2026, 2:29:41 pm, 19.4 19.4 15.3.(b)(6) on (b)(6) 2026, 4:11:01 pm, 22.5 22.5 16.2.(b)(6) on (b)(6) 2026, 4:41:38 pm, 20.6 20.6 17.8.(b)(6) on (b)(6) 2026, 4:44:36 am, 20 20 18.6.(b)(6) on (b)(6) 2026, 12:04:44 pm, 20.7 20.7 18.6.(b)(6) on 2026, 5:03:34 pm, 21 21 19.(b)(6) 02/09/2026, 7:44:54 pm, 20.3 20.3 21.3 18.7 no impact to patient management was 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: 24927943
• Report Number: 3005094123-2026-00188
• Device Sequence Number: 5357141
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/12/2026

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: 07P70-20
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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