TPLC - Total Product Life Cycle

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Device	culture media, non-propagating transport
Regulation Description	Transport culture medium.
Product Code	JSM
Regulation Number	866.2390
Device Class	1

Premarket Reviews
Manufacturer	Decision
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 SPA
	SUBSTANTIALLY EQUIVALENT	3
ENSOL BIOSCIENCES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HANCHANG MEDIC CO., LTD. (HAN CHANG MEDIC)
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU ALLTEST BIOTECH CO., LTD.
	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
JINAN BABIO BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL WIRE & EQUIPMENT COMPANY (BATH), 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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	34	34
Product Quality Problem	25	25
Incorrect, Inadequate or Imprecise Result or Readings	21	22
Break	11	11
Fluid/Blood Leak	11	11
Short Fill	11	11
Separation Problem	10	10
Device Contamination with Chemical or Other Material	10	10
Contamination /Decontamination Problem	8	8
Device Ingredient or Reagent Problem	7	7
Device Markings/Labelling Problem	7	7
Delivered as Unsterile Product	7	7
Volume Accuracy Problem	6	6
Component Missing	5	5
Physical Resistance/Sticking	4	4
Contamination	4	5
Overfill	4	4
Premature Separation	3	3
Missing Information	3	3
Detachment of Device or Device Component	3	3
Tear, Rip or Hole in Device Packaging	3	3
Material Separation	3	3
Complete Blockage	2	2
Material Puncture/Hole	2	2
Unsealed Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Material Discolored	2	2
Noise, Audible	1	1
Improper or Incorrect Procedure or Method	1	1
False Positive Result	1	1
Inaccurate Information	1	1
Coagulation in Device or Device Ingredient	1	1
Contamination of Device Ingredient or Reagent	1	1
Packaging Problem	1	1
Material Deformation	1	1
Misassembly During Maintenance/Repair	1	1
Flare or Flash	1	1
Difficult to Insert	1	1
Defective Device	1	1
Insufficient Information	1	1
Filling Problem	1	1
Crack	1	1
Off-Label Use	1	1
Material Opacification	1	1
Mechanical Problem	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	195	196
Insufficient Information	9	10
No Consequences Or Impact To Patient	6	6
Needle Stick/Puncture	5	5
Chemical Exposure	1	1
No Patient Involvement	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	Krishe Inc	II	Apr-13-2021
7	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022