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TPLC
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show TPLC since
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Device
photometric method, magnesium
Product Code
JGJ
Regulation Number
862.1495
Device Class
1
Premarket Reviews
Manufacturer
Decision
ABAXIS, INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORP.
SUBSTANTIALLY EQUIVALENT
1
RANDOX LABORATORIES LTD
SUBSTANTIALLY EQUIVALENT
1
SEKISUI DIAGNOSTICS P.E.I. INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
24
24
2016
4
4
2017
18
18
2018
21
21
2019
31
31
2020
34
34
2021
33
33
2022
42
42
2023
32
32
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
195
195
Low Test Results
36
36
Incorrect, Inadequate or Imprecise Result or Readings
26
26
Incorrect Or Inadequate Test Results
7
7
Non Reproducible Results
4
4
Leak/Splash
1
1
Mechanical Problem
1
1
Crack
1
1
Degraded
1
1
False Positive Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
117
117
No Known Impact Or Consequence To Patient
96
96
No Consequences Or Impact To Patient
35
35
Insufficient Information
7
7
No Code Available
3
3
Misdiagnosis
2
2
No Patient Involvement
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories, Inc
II
Mar-01-2019
2
Beckman Coulter Inc.
II
Feb-28-2022
3
Horiba Instruments, Inc dba Horiba Medical
II
Sep-24-2014
4
Ortho-Clinical Diagnostics
II
Nov-15-2013
5
Randox Laboratories Ltd.
II
Dec-08-2020
6
Randox Laboratories, Limited
II
Dec-08-2016
7
Siemens Healthcare Diagnostics, Inc.
II
Sep-26-2022
8
Siemens Healthcare Diagnostics, Inc.
II
Mar-28-2022
9
Siemens Healthcare Diagnostics, Inc.
II
Nov-25-2015
10
Siemens Healthcare Diagnostics, Inc.
II
Apr-17-2012
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