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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device covid-19 multi-analyte antigen device
Definition A COVID-19 Multi-Analyte Antigen Device is a test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be interpreted in the context of clinical observations, patient history, and/or epidemiological information, patient history, and/or epidemiological information.
Product CodeQMN
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 1 1
2021 40 40
2022 2208 2208
2023 576 576
2024 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 2760 2760
False Positive Result 2480 2480
False Negative Result 263 263
Erratic Results 125 125
Incorrect, Inadequate or Imprecise Result or Readings 48 48
Non Reproducible Results 9 9
Leak/Splash 2 2
Product Quality Problem 2 2
Device Handling Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
High Readings 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2918 2918
Insufficient Information 120 120
Diarrhea 1 1
Virus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jun-02-2023
2 Ortho Clinical Diagnostics Inc II Nov-13-2020
3 PHASE SCIENTIFIC INTERNATIONAL LIMITED II Jan-17-2024
4 Quidel Corporation II Feb-14-2024
5 VEO DIAGNOSTICS, LLC II Dec-01-2020
6 Versea Diagnostics LLC II Sep-03-2021
-
-