MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division Alinity i Total B-hCG Reagent Kit; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Catalog Number	07P51-21
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed positive alinity i total bhcg results on a patient.Id (b)(6) 2 (42 year old female) generated alinity i total bhcg of 59 miu/ml (positive) on a serum sample, but the urine test was negative.The patient was tested for bhcg roche method, bhcg quidel-ortho vitros method, heterophilic antibodies, hcg tumor testing and all results were negative.Additionally, different samples from the same patient were tested with differing results.Data provided: 12may: id(b)(6) alinity result: 17 miu/ml 27may: id (b)(6) alinity result: 21 miu/ml 29may: id (b)(6) alinity result: 20 miu/ml 21jun: id (b)(6) alinity result: 59 miu/ml 26jun: id (b)(6) alinity result: 70 miu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity i total b-hcg reagent lot 81524ud00 to address the customer¿s observation of falsely elevated 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.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 81525ud00 (which contains the same bulk material as lot 81524ud00) stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Testing of customer samples was performed.Two samples, 000008830254 (gold top) and 000008830254 (red top), were tested using a retained alinity i total b-hcg reagent kit from lot 85553ud00.The assay was calibrated, and the calibration met instrument specifications.All control results met established acceptance criteria and were within the typical range.The results obtained are consistent with heterophilic antibody interference causing falsely elevated b-hcg results in the alinity i total b-hcg assay.Labelling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity i total b-hcg reagent lot 81524ud00.

• Brand Name: Alinity i Total B-hCG Reagent Kit
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 50134007
• Report Number: 3005094123-2026-00379
• Device Sequence Number: 20243260
• Product Code: DHA
• UDI-Device Identifier: 00380740160616
• UDI-Public: (01)00380740160616(17)261009(10)81524UD00
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170317
• 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,Followup
• Report Date (Section B): 09/17/2026

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: 07P51-21
• Device Lot Number: 81524UD00
• 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: 07/20/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2025
• 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 Age: 42 YR
• Patient Sex: Female