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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, non-propagating transport
Product CodeJSM
Regulation Number 866.2390
Device Class 1


Premarket Reviews
ManufacturerDecision
ARX SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZER SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEKE CORPORATION (WUXI) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
COPAN ITALIA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUACHENYANG (SHENZHEN) TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDSCHENKER, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 81 81
2020 47 47
2021 41 41
2022 36 36
2023 48 48
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 57 57
Leak/Splash 39 39
Break 23 23
Short Fill 20 20
Volume Accuracy Problem 14 14
Product Quality Problem 12 12
Fluid/Blood Leak 11 11
Device Markings/Labelling Problem 10 10
Delivered as Unsterile Product 9 9
Material Protrusion/Extrusion 8 8
Device Contamination with Chemical or Other Material 8 8
Separation Problem 8 8
Component Missing 5 5
Device Ingredient or Reagent Problem 4 4
Overfill 4 4
Contamination 4 4
Physical Resistance/Sticking 4 4
Missing Information 3 3
Appropriate Term/Code Not Available 3 3
Contamination /Decontamination Problem 3 3
Material Separation 3 3
Improper or Incorrect Procedure or Method 3 3
Microbial Contamination of Device 2 2
Detachment of Device or Device Component 2 2
Complete Blockage 2 2
Material Discolored 2 2
False Positive Result 2 2
Material Puncture/Hole 2 2
Difficult to Insert 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Premature Separation 2 2
Misassembly During Maintenance/Repair 1 1
Packaging Problem 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Material Deformation 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Material Opacification 1 1
Filling Problem 1 1
False Negative Result 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Flare or Flash 1 1
Contamination of Device Ingredient or Reagent 1 1
Defective Device 1 1
Shipping Damage or Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
No Known Impact Or Consequence To Patient 77 77
No Consequences Or Impact To Patient 18 18
Needle Stick/Puncture 15 15
Foreign Body In Patient 12 12
No Patient Involvement 6 6
Insufficient Information 6 6
Exposure to Body Fluids 3 3
Blood Loss 2 2
No Information 2 2
No Code Available 1 1
Chemical Exposure 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems, Inc. II Oct-08-2022
2 American Contract Systems, Inc. I Jul-01-2022
3 Gentueri Inc II Feb-04-2022
4 Gentueri Inc II Jan-18-2022
5 Hardy Diagnostics II Dec-21-2020
6 Krishe Inc II Apr-13-2021
7 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
8 Merit Medical Systems, Inc. II Nov-16-2020
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