TPLC - Total Product Life Cycle

• Device: reagent, occult blood
• Product Code: KHE
• Regulation Number: 864.6550
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALFA SCIENTIFIC DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EIKEN CHEMICAL CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
ENTERIX INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU WONDFO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMMUNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
IND DIAGNOSTIC INC.
	SUBSTANTIALLY EQUIVALENT	1
IND DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIENT GENE BIOTECH
	SUBSTANTIALLY EQUIVALENT	1
PRINCETON BIOMEDITECH CORP.
	SUBSTANTIALLY EQUIVALENT	1
SEKISUI DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	10	10
2016	3	3
2017	1	1
2018	1	1
2019	1	1
2020	1	1
2021	2	2
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	9	9
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Device Markings/Labelling Problem	3	3
Manufacturing, Packaging or Shipping Problem	1	1
Incorrect Or Inadequate Test Results	1	1
Overheating of Device	1	1
Expulsion	1	1
Product Quality Problem	1	1
Material Integrity Problem	1	1
Device Inoperable	1	1
Expiration Date Error	1	1
Contamination /Decontamination Problem	1	1
Melted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	11	11
No Consequences Or Impact To Patient	9	9
No Patient Involvement	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Exposure to Body Fluids	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alere North Americal	II	Apr-28-2011
2	Assuramed	II	Sep-13-2013
3	Beckman Coulter Inc.	II	Aug-22-2013
4	Cypress Medical Products LLC	III	Mar-30-2019
5	Enterix, Inc.	II	Dec-15-2020
6	Helena Laboratories, Corp.	II	Jul-05-2019
7	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
8	Polymedco, Inc	II	Apr-04-2013
9	Roche Diagnostics Corporation	II	Oct-31-2018