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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
Regulation Description 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
2016 1 1
2017 10 10
2018 4 4
2019 5 5
2020 1 1
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 5 5
Device Markings/Labelling Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Labelling, Instructions for Use or Training Problem 3 3
Leak/Splash 2 2
False Negative Result 1 1
Fluid Leak 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
Adverse Event Without Identified Device or Use Problem 1 1
Device Handling Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 4 4
No Patient Involvement 3 3
No Information 2 2
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 BIOMERIEUX - Grenoble II Feb-11-2020
2 Becton Dickinson & Co. III Apr-28-2018
3 BioMerieux SA II Oct-23-2018
4 BioMerieux SA II Nov-09-2017
5 BioMerieux SA II Mar-19-2017
6 BioMerieux SA I Jan-13-2017
7 DNA Genotek Inc. III Sep-23-2020
8 Ventana Medical Systems Inc I Sep-14-2018
9 Ventana Medical Systems Inc I Feb-27-2018
10 bioMerieux, Inc. II Nov-09-2018
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