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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 41 41
2022 2081 2081

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 2043 2043
False Positive Result 1966 1966
False Negative Result 116 116
Erratic Results 26 26
Incorrect, Inadequate or Imprecise Resultor Readings 25 25
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2116 2116
Insufficient Information 120 120
Diarrhea 1 1
Virus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Nov-13-2020
2 VEO DIAGNOSTICS, LLC II Dec-01-2020
3 Versea Diagnostics LLC II Sep-03-2021
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