MAUDE Adverse Event Report: Abbott Laboratories Alinity s HIV Ag/Ab Combo Reagent Kit; Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donatio

Catalog Number	06P01-61
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed false reactive alinity s hiv ag/ab combo and provided the following data: sample id (b)(6) results are 1.84, 2.84, and 2.86.Nat: negative.Sample id (b)(6) results are 1.41, 1.43, and 1.49.Nat: negative.Sample id (b)(6) results are 1.07, 2.35, and non-reactive (result not provided).Nat: negative.Sample id (b)(6) results are 1.00, 6.66, and non-reactive (result not provided).Nat: negative.Sample id (b)(6) results are 15.65, 34.64, and 4.10.Nat: negative.Sample id (b)(6) results are 13.15, 18.05, and 30.90.Nat: negative.Sample id (b)(6) results are 4.04, 4.06, and 6.20.Nat: negative.Sample id (b)(6) results are 10.93, 19.58, and 20.23.Nat: negative.Sample id (b)(6) results are 37.48, 45.01, and 43.48.Nat: negative.No results were provided for sample ids (b)(6) and (b)(6).The customer reported that all samples generated negative nat results.The customer further communicated that the samples were for the purpose of tissue donation, however the customer confirmed discrepant results were not reported out to the medical provider.There was no reported impact to patient management.
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.

• Brand Name: Alinity s HIV Ag/Ab Combo Reagent Kit
• Common Device Name: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donatio
• Manufacturer (Section D): Abbott Laboratories; 100 abbott park road; abbott park IL 60064
• Manufacturer (Section G): Abbott Laboratories; 100 abbott park road; abbott park IL 60064
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; +49()6122582960
• MDR Report Key: 50595564
• Report Number: 1415939-2026-00023
• Device Sequence Number: 13158402
• Product Code: SDN
• UDI-Device Identifier: 00380740202859
• UDI-Public: (01)00380740202859(17)261011(10)81038MM00
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: BL 125679
• 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): 10/01/2026

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: 06P01-61
• Device Lot Number: 81038MM00
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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 S SYSTEM, 06P16-01, (b)(6)
• Patient Sex: Unknown