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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
2018 4 4
2019 5 5
2020 1 1
2021 12 12
2022 31 31
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 23 23
Low Test Results 8 8
Device Markings/Labelling Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Improper or Incorrect Procedure or Method 2 2
Contamination 2 2
Leak/Splash 2 2
Unable to Obtain Readings 1 1
False Negative Result 1 1
Fluid/Blood Leak 1 1
Failure to Analyze Signal 1 1
Shipping Damage or Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Insufficient Information 3 3
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 2 2
Chemical Exposure 2 2
Death 1 1
Burn(s) 1 1
Eye Injury 1 1
Reaction 1 1
Skin Discoloration 1 1
No Consequences Or Impact To Patient 1 1
Fall 1 1
Irritation 1 1
Loss of Vision 1 1
No Information 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 Cytocell Ltd. III Mar-24-2022
6 DNA Genotek Inc. III Sep-23-2020
7 Ortho-Clinical Diagnostics, Inc. II Jan-18-2022
8 Ventana Medical Systems Inc I Sep-14-2018
9 Ventana Medical Systems Inc I Feb-27-2018
10 bioMerieux, Inc. II Aug-23-2022
11 bioMerieux, Inc. II Nov-09-2018
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