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TPLC
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show TPLC since
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Device
enzymatic, carbon-dioxide
Product Code
KHS
Regulation Number
862.1160
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALFA WASSERMANN
SUBSTANTIALLY EQUIVALENT
1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER IRELAND INC
SUBSTANTIALLY EQUIVALENT
1
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
ELITECHGROUP
SUBSTANTIALLY EQUIVALENT
1
HITACHI CHEMICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
RANDOX LABORATORIES LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
TECO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
1
1
2016
4
4
2017
7
7
2018
15
15
2019
35
35
2020
31
31
2021
14
14
2022
10
10
2023
25
25
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
75
75
Low Test Results
64
64
Incorrect, Inadequate or Imprecise Result or Readings
25
25
Incorrect Measurement
2
2
Incorrect Or Inadequate Test Results
2
2
Inadequate Storage
1
1
High Readings
1
1
Device Operates Differently Than Expected
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
64
64
No Known Impact Or Consequence To Patient
57
57
No Patient Involvement
20
20
No Consequences Or Impact To Patient
19
19
Coma
1
1
Misdiagnosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott GmBH & Co. KG
II
Nov-26-2019
2
Beckman Coulter Inc.
II
May-18-2023
3
Ortho-Clinical Diagnostics
II
Nov-15-2013
4
Ortho-Clinical Diagnostics, INc.
II
Dec-07-2023
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