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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 196 196

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 2853 2853
False Positive Result 2563 2563
False Negative Result 272 272
Erratic Results 125 125
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Non Reproducible Results 11 11
Leak/Splash 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Markings/Labelling Problem 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Contamination of Device Ingredient or Reagent 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 3014 3014
Insufficient Information 120 120
Virus 1 1
Diarrhea 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
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