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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
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, Inadequate or Imprecise Result or Readings 3 3
Improper or Incorrect Procedure or Method 2 2
Contamination 2 2
Leak/Splash 2 2
Unable to Obtain Readings 1 1
Fluid/Blood Leak 1 1
Device Contamination with Chemical or Other Material 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
Insufficient Information 3 3
Chemical Exposure 2 2
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
Eye Injury 1 1
Fall 1 1
Irritation 1 1
Loss of Vision 1 1
No Consequences Or Impact To Patient 1 1
Reaction 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 Cytocell Ltd. III Mar-24-2022
5 DNA Genotek Inc. III Sep-23-2020
6 NeuMoDx Molecular Inc II Jul-28-2023
7 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
8 bioMerieux, Inc. II Aug-23-2022
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