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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 26 26
Device Markings/Labelling Problem 9 9
Low Test Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Incorrect Or Inadequate Test Results 5 5
Improper or Incorrect Procedure or Method 5 5
Labelling, Instructions for Use or Training Problem 3 3
Leak/Splash 2 2
Contamination 2 2
False Negative Result 1 1
Device Damaged Prior to Use 1 1
Non Reproducible Results 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Unable to Obtain Readings 1 1
Shipping Damage or Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Missing Information 1 1
Device Operates Differently Than Expected 1 1
Failure to Analyze Signal 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Hypersensitivity/Allergic reaction 4 4
No Known Impact Or Consequence To Patient 4 4
No Information 3 3
No Patient Involvement 3 3
Insufficient Information 3 3
Chemical Exposure 2 2
Irritation 2 2
Reaction 2 2
No Consequences Or Impact To Patient 2 2
Death 1 1
Misdiagnosis 1 1
Skin Discoloration 1 1
Burn(s) 1 1
Rash 1 1
Fall 1 1
Eye Injury 1 1
Loss of Vision 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 Jul-03-2024
13 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
14 Ventana Medical Systems Inc I Sep-14-2018
15 Ventana Medical Systems Inc I Feb-27-2018
16 bioMerieux, Inc. II Aug-23-2022
17 bioMerieux, Inc. II Nov-09-2018
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