Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDELORTHO CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUIDELORTHO CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB Back to Search Results
Catalog Number 20377
Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a review of complaint history did not identify any adverse trends for the reported issue for this lot.A review of the dhr found that the lot met all release criteria.Root cause: unable to determine source: phone.
 
Event Description
Customer reporting 8 false negative results, 6 for sars, 1 for flu a, 1 for flu b.Customer states the results were positive by pcr.Report 2 of 8 (sars).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
Type of Device
SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
Manufacturer (Section D)
QUIDELORTHO CORPORATION
10165 mckellar court
san diego CA 92121
Manufacturer Contact
karl luke
10165 mckellar court
san diego, CA 92121
MDR Report Key18966197
MDR Text Key338432322
Report Number0002024674-2024-00202
Device Sequence Number1
Product Code QMN
UDI-Device Identifier30014613339229
UDI-Public30014613339229
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA202751
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number20377
Device Lot Number709177
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-