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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 respiratory panel nucleic acid devices
Definition Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, 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 used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Product CodeQLT
Device Class Not Classified

MDR Year MDR Reports MDR Events
2021 392 392
2022 900 900
2023 283 283
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 885 885
False Positive Result 713 713
Incorrect, Inadequate or Imprecise Result or Readings 388 388
Output Problem 353 353
False Negative Result 48 48
No Apparent Adverse Event 17 17
Erratic Results 12 12
No Device Output 5 5
Unable to Obtain Readings 4 4
Insufficient Information 4 4
Device Sensing Problem 2 2
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1602 1602
Anxiety 564 564
Unspecified Respiratory Problem 563 563
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 NeuMoDx Molecular Inc II Jun-08-2022
2 Qiagen GmbH II Jul-27-2023
3 Qiagen Sciences LLC II Jun-02-2023
4 Qiagen Sciences LLC II Jan-05-2022
5 Qiagen Sciences LLC II Sep-04-2020
6 Roche Molecular Systems, Inc. II Feb-07-2023
7 Roche Molecular Systems, Inc. II Sep-21-2021
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