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TPLC
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show TPLC since
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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
2024
2
2
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
Expulsion
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Expiration Date Error
1
1
Incorrect Or Inadequate Test Results
1
1
Product Quality Problem
1
1
Melted
1
1
Overheating of Device
1
1
Device Inoperable
1
1
Contamination /Decontamination Problem
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
Insufficient Information
3
3
No Clinical Signs, Symptoms or Conditions
2
2
No Patient Involvement
2
2
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
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