MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TSH REAGENT KIT; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number	07P48-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information has been included.No additional patient details are available.Section a patient information: refer to section b5 for complete patient information.A complaint investigation was conducted for the alinity i tsh reagent lot 76105ud00 to address the customer¿s observation of falsely depressed results.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.The overall performance of alinity i tsh reagents in the field was reviewed using worldwide data.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Labeling review concludes that the issue is adequately addressed.Based on our investigation, no systemic issue or deficiency was identified with the alinity i tsh reagent lot 76105ud00.
Event or Problem Description
The customer observed falsely depressed alinity i tsh results for two samples.The following data was provided (reference range: 0.4 to 4.5 uiu/ml): (b)(6) 2026, sid (b)(6), initial result 0.0164 uiu/ml, repeated on (b)(6) 2026 1.738 miu/ml.(b)(6) 2026, sid (b)(6), initial result <0.01 uiu/ml, recollected a new sample on (b)(6) 2026 sid (b)(6), result was 1.728 uiu/ml.No impact to patient management was reported.

• Brand Name: ALINITY I TSH REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 24442205
• Report Number: 3005094123-2026-00091
• Device Sequence Number: 21423618
• Product Code: JLW
• UDI-Device Identifier: 00380740131159
• UDI-Public: (01)00380740131159(17)261101(10)76105UD00
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K983442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 07P48-30
• Device Lot Number: 76105UD00
• 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: 02/06/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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)
• Patient Sex: Unknown