MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M RESP-4-PLEX AMP KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	09N79-096
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.Additional mdr submitted for the additional run date: 3005248192-2026-00036 16-mar-2026.
Event or Problem Description
The customer reported two (02) false positive results for the rsv target on the alinity m resp-4-plex amp kit.Patient 1: sample id (sid): (b)(6) was processed on 16-mar-2026 and resulted as rsv positive with a cycle threshold (ct) value of 39.11.Repeat testing on the cepheid platform produced a not detected result for rsv.Patient 2 (15-month old patient): sid: (b)(6) was processed on 10-mar-2026 and resulted as rsv positive with a ct value of 39.10.Repeat testing on the cepheid platform produced a not detected result.The specimen type was a nasopharyngeal (np) swab collected in bd universal viral transport (uvt).Repeat testing was performed using the original sample tube.At the customer site for multiplex assays if two or more targets return a positive result, the sample is retested on another platform.There was no report of impact to patient management.

• Brand Name: ALINITY M RESP-4-PLEX AMP KIT
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 24840566
• Report Number: 3005248192-2026-00037
• Device Sequence Number: 9928185
• Product Code: QJR
• UDI-Device Identifier: 00884999049390
• UDI-Public: (01)00884999049390(10)444189(17)261120(240)09N79-096
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 09N79-096
• Device Lot Number: 444189
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2025
• 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
• Patient Age: 15 MO
• Patient Sex: Unknown