MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS SOFIA SARS ANTIGEN FIA, NS SWAB

Catalog Number	20374
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the provided lot number was not associated with the reported product.Therefore, we performed a search for similar complaints of the reported problem.A review of the product did not find any unusual trend for the reported complaint category.Without a lot number, no further investigation can be conducted.Root cause: insufficient info.Source: phone.
Event or Problem Description
Reports suspected false negative results, uncomfirmed with alternate test method.Unknown if patients were symptomatic.No apparent adverse event.Excat number of suspected false positves not provided.

• Brand Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Common Device Name: SOFIA SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 22667158
• Report Number: 0002024674-2025-00440
• Device Sequence Number: 14372077
• Product Code: QKP
• UDI-Device Identifier: 30014613339083
• UDI-Public: (01)30014613339083
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200742
• 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): 07/30/2025

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: 20374
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/30/2025
• 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