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TPLC
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show TPLC since
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Device
azo dye, calcium
Product Code
CJY
Regulation Number
862.1145
Device Class
2
Premarket Reviews
Manufacturer
Decision
ELITECHGROUP
SUBSTANTIALLY EQUIVALENT
1
HORIBA ABX S.A.S.
SUBSTANTIALLY EQUIVALENT
1
HORIBA ABX SAS
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES LTD.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
4
4
2016
3
3
2017
26
26
2018
21
21
2019
29
29
2020
33
33
2021
24
24
2022
17
17
2023
29
29
2024
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
108
108
Low Test Results
89
89
Incorrect Or Inadequate Test Results
4
4
Packaging Problem
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Adverse Event Without Identified Device or Use Problem
3
3
High Readings
1
1
Fluid/Blood Leak
1
1
Low Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
97
97
No Clinical Signs, Symptoms or Conditions
94
94
No Consequences Or Impact To Patient
19
19
Test Result
2
2
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics
II
Jul-23-2016
2
Ortho-Clinical Diagnostics
II
Nov-15-2013
3
Randox Laboratories Ltd.
II
Feb-15-2019
4
SEPPIM SAS
II
Nov-07-2013
5
Siemens Healthcare Diagnostics, Inc.
II
Apr-14-2022
6
Vital Diagnostics, Inc.
II
Jan-14-2014
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