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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrumentation for clinical multiplex test systems
Definition Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
Product CodeNSU
Regulation Number 862.2570
Device Class 2

MDR Year MDR Reports MDR Events
2020 3 3
2021 4 4
2022 24 24
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Output Problem 17 17
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Negative Result 3 3
Failure of Device to Self-Test 3 3
False Positive Result 3 3
Insufficient Information 2 2
Defective Component 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 17 17
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Sep-11-2024
2 BioFire Diagnostics, LLC II Nov-20-2023
3 Hologic, Inc II Apr-07-2021
4 Hologic, Inc II Sep-21-2020
5 Luminex Corporation II Apr-13-2022
6 Roche Molecular Systems, Inc. II Oct-17-2022
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