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TPLC
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show TPLC since
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Device
fluorometric method, cpk or isoenzymes
Product Code
JHX
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
MITSUBISHI KAGAKU IATRON
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
17
17
2015
8
8
2016
10
10
2017
3
3
2018
16
16
2019
7
7
2020
3
3
2021
10
10
2022
2
2
2023
2
2
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
26
26
Incorrect Or Inadequate Test Results
14
14
Low Test Results
14
14
Incorrect, Inadequate or Imprecise Result or Readings
13
13
High Readings
5
5
False Positive Result
4
4
Adverse Event Without Identified Device or Use Problem
2
2
Malposition of Device
1
1
Low Readings
1
1
No Apparent Adverse Event
1
1
Device Displays Incorrect Message
1
1
Use of Device Problem
1
1
Computer Software Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
29
29
No Consequences Or Impact To Patient
29
29
No Clinical Signs, Symptoms or Conditions
16
16
No Code Available
2
2
Test Result
1
1
Misdiagnosis
1
1
No Information
1
1
Chest Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Dade Behring, Inc.
II
Jan-28-2009
2
Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc
II
Sep-17-2018
3
Siemens Healthcare Diagnostics
II
Mar-21-2012
4
Siemens Healthcare Diagnostics Inc
II
Aug-11-2016
5
Siemens Healthcare Diagnostics Inc
II
Jan-07-2016
6
Siemens Healthcare Diagnostics, Inc.
II
Nov-10-2010
7
Tosoh Bioscience Inc
II
Jun-05-2018
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