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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device general purpose reagent
Definition A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.
Product CodePPM
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 10 10
2018 4 4
2019 5 5
2020 1 1
2021 12 12
2022 31 31
2023 7 7
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 26 26
Device Markings/Labelling Problem 8 8
Low Test Results 8 8
Incorrect Or Inadequate Test Results 5 5
Improper or Incorrect Procedure or Method 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Labelling, Instructions for Use or Training Problem 3 3
Leak/Splash 2 2
Contamination 2 2
False Negative Result 1 1
Fluid/Blood Leak 1 1
Unable to Obtain Readings 1 1
Failure to Analyze Signal 1 1
Shipping Damage or Problem 1 1
Device Damaged Prior to Use 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Device Fell 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 4 4
No Information 3 3
Insufficient Information 3 3
No Patient Involvement 3 3
No Consequences Or Impact To Patient 2 2
Reaction 2 2
Chemical Exposure 2 2
Irritation 2 2
Rash 1 1
Skin Discoloration 1 1
Loss of Vision 1 1
Misdiagnosis 1 1
Burn(s) 1 1
Death 1 1
Eye Injury 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agilent Technologies, Inc. III Jul-14-2022
2 BIOMERIEUX - Grenoble II Feb-11-2020
3 Beckman Coulter, Inc. II Mar-25-2024
4 Becton Dickinson & Co. III Apr-28-2018
5 BioMerieux SA II Oct-23-2018
6 BioMerieux SA II Nov-09-2017
7 BioMerieux SA II Mar-19-2017
8 BioMerieux SA I Jan-13-2017
9 Cytocell Ltd. III Mar-24-2022
10 DNA Genotek Inc. III Sep-23-2020
11 NeuMoDx Molecular Inc II Jul-28-2023
12 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
13 Ventana Medical Systems Inc I Sep-14-2018
14 Ventana Medical Systems Inc I Feb-27-2018
15 bioMerieux, Inc. II Aug-23-2022
16 bioMerieux, Inc. II Nov-09-2018
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