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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 46
2022 2208 2210
2023 576 576
2024 407 407
2025 388 388

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 3216 3218
False Positive Result 2941 2943
False Negative Result 395 395
Erratic Results 147 147
Incorrect, Inadequate or Imprecise Result or Readings 70 76
Unable to Obtain Readings 42 42
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
Inaccurate Information 2 2
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3425 3433
Insufficient Information 290 290
Viral Infection 17 17
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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