MAUDE Adverse Event Report: Quidel Corporation dba Ortho-Clinical Diagnostics Sofia2 Flu + SARS Antigen FIA, NS swab

Catalog Number	20377
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported dual positive influenza b and sars result on three (3) occassions.Unknown confirmatory testing.Unknown if patient was symptomatic.Report 3 of 3.
Additional Manufacturer Narrative
An investigation could not be performed due to insufficient information, including the absence of lot information.Therefore, the cause of the reported event could not be established.The source of the complaint was an email.

• Brand Name: Sofia2 Flu + SARS Antigen FIA, NS swab
• Common Device Name: Sofia2 Flu + SARS Antigen FIA, NS swab
• Manufacturer (Section D): Quidel Corporation dba Ortho-Clinical Diagnostics; 100 indigo creek dr; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek dr; rochester, NY 14626
• MDR Report Key: 50776378
• Report Number: 0002024674-2026-00113
• Device Sequence Number: 18830004
• Product Code: QMN
• UDI-Device Identifier: 30014613339229
• UDI-Public: (01)30014613339229
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EUA202751
• Number of Events Summarized: 1
• Summary Report (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): 08/17/2026

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: 20377
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown