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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 407 407
2025 214 214

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 3141 3141
False Positive Result 2841 2841
False Negative Result 370 370
Erratic Results 135 135
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Unable to Obtain Readings 16 16
Non Reproducible Results 11 11
Device Markings/Labelling Problem 4 4
Leak/Splash 2 2
Device Contaminated During Manufacture or Shipping 2 2
Insufficient Information 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 3288 3288
Insufficient Information 254 254
Viral Infection 16 16
Virus 1 1
Fever 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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