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: QUIDEL CORPORATION SOLANA SARS-COV-2 ASSAY (LYO MMX)
  • 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
 

QUIDEL CORPORATION SOLANA SARS-COV-2 ASSAY (LYO MMX) Back to Search Results
Catalog Number M312
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2022
Event Type  malfunction  
Event Description
Customer reporting 1 discordant sars result between two instruments.No confirmation testing was performed, and symptomatic status of patient is unknown.
 
Manufacturer Narrative
Investigation conclusion: through technical interview it was found the customer was using expired media and the sample in question was mucoid and not processed correctly.Follow up with customer shows assay is performing as expected after change in media and sample processing tips.Root cause: possible technician processing error and/or contamination from expired media.Source: phone.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOLANA SARS-COV-2 ASSAY (LYO MMX)
Type of Device
SOLANA SARS-COV-2 ASSAY (LYO MMX)
Manufacturer (Section D)
QUIDEL CORPORATION
2005 east state street
athens OH 45701
Manufacturer Contact
karl luke
2005 east state street
athens, OH 45701
7405893382
MDR Report Key16244960
MDR Text Key308356167
Report Number0002024674-2023-00096
Device Sequence Number1
Product Code QJR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA203087
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 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberM312
Device Lot Number224756
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-