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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
2017 10 10
2018 4 4
2019 5 5
2020 1 1
2021 12 12
2022 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 22 22
Low Test Results 8 8
Device Markings/Labelling Problem 6 6
Improper or Incorrect Procedure or Method 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Or Inadequate Test Results 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
Failure to Analyze Signal 1 1
Shipping Damage or Problem 1 1
Device Damaged Prior to Use 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 41 41
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 4 4
No Patient Involvement 3 3
Insufficient Information 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
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 Becton Dickinson & Co. III Apr-28-2018
4 BioMerieux SA II Oct-23-2018
5 BioMerieux SA II Nov-09-2017
6 BioMerieux SA II Mar-19-2017
7 BioMerieux SA I Jan-13-2017
8 Cytocell Ltd. III Mar-24-2022
9 DNA Genotek Inc. III Sep-23-2020
10 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
11 Ventana Medical Systems Inc I Sep-14-2018
12 Ventana Medical Systems Inc I Feb-27-2018
13 bioMerieux, Inc. II Aug-23-2022
14 bioMerieux, Inc. II Nov-09-2018
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