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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
ALB LUZ
  SUBSTANTIALLY EQUIVALENT 1
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 3
ENSOL BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
HANCHANG MEDIC CO., LTD. (HAN CHANG MEDIC)
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU GENESIS BIODETECTION & BIOCONTROL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HARDY DIAGNOSTICS
  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 2
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 47 47
2021 41 41
2022 36 36
2023 48 48
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Incorrect, Inadequate or Imprecise Result or Readings 19 19
Leak/Splash 16 16
Short Fill 16 16
Product Quality Problem 12 12
Volume Accuracy Problem 12 12
Fluid/Blood Leak 11 11
Device Contamination with Chemical or Other Material 10 10
Delivered as Unsterile Product 9 9
Separation Problem 8 8
Device Markings/Labelling Problem 7 7
Component Missing 5 5
Device Ingredient or Reagent Problem 5 5
Contamination 4 4
Physical Resistance/Sticking 4 4
Overfill 4 4
Material Protrusion/Extrusion 4 4
Contamination /Decontamination Problem 3 3
Material Separation 3 3
Detachment of Device or Device Component 3 3
Missing Information 3 3
Complete Blockage 2 2
Material Puncture/Hole 2 2
Insufficient Information 2 2
Microbial Contamination of Device 2 2
Difficult to Insert 2 2
Material Discolored 2 2
Appropriate Term/Code Not Available 2 2
Premature Separation 2 2
False Positive Result 2 2
Improper or Incorrect Procedure or Method 2 2
Filling Problem 1 1
Crack 1 1
Defective Device 1 1
Shipping Damage or Problem 1 1
Flare or Flash 1 1
Misassembly During Maintenance/Repair 1 1
Material Opacification 1 1
Material Deformation 1 1
Packaging Problem 1 1
Mechanical Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination of Device Ingredient or Reagent 1 1
False Negative Result 1 1
Coagulation in Device or Device Ingredient 1 1
Nonstandard Device 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 131
No Consequences Or Impact To Patient 17 17
Foreign Body In Patient 12 12
No Known Impact Or Consequence To Patient 10 10
Needle Stick/Puncture 8 8
Insufficient Information 7 7
No Patient Involvement 6 6
Blood Loss 2 2
No Code Available 1 1
Chemical Exposure 1 1
Exposure to Body Fluids 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 Cepheid II Aug-14-2024
4 Gentueri Inc II Feb-04-2022
5 Gentueri Inc II Jan-18-2022
6 Hardy Diagnostics II Dec-21-2020
7 Krishe Inc II Apr-13-2021
8 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
9 Merit Medical Systems, Inc. II Nov-16-2020
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