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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the complaint history on the reported lot was reviewed and no trends were identified.Upon further review of the information provided in the case details, a root cause could not be determined.This issue will be continuously monitored through incoming complaints.Root cause: unable to determine.Source: phone.
Event or Problem Description
Reports increase in positive results, analyte not specified, number of tests not specified.Confirmation not performed.Patients wer symptomatic.No apparent adverse event.

• 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; 10165 mckellar court; san diego 92121
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25534972
• Report Number: 0002024674-2026-00089
• Device Sequence Number: 13179263
• Product Code: QMN
• UDI-Device Identifier: 30014613339229
• UDI-Public: (01)30014613339229(10)376234(11)261103(17)251223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EUA202751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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
• Device Lot Number: 376234
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• 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