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TPLC
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show TPLC since
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2024
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Device
culture media, non-propagating transport
Product Code
JSM
Regulation Number
866.2390
Device Class
1
Premarket Reviews
Manufacturer
Decision
ARX SCIENCES, 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
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
57
57
Leak/Splash
38
38
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
Separation Problem
8
8
Device Contamination with Chemical or Other Material
7
7
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
112
112
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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