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

• 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: 50776391
• Report Number: 0002024674-2026-00112
• Device Sequence Number: 13432695
• 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