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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product Code
LOM
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
49
46
124
127
46
46
38
46
57
73
36
53
60
70
64
14
MDR Year
MDR Reports
MDR Events
2014
129
129
2015
139
139
2016
146
146
2017
88
88
2018
112
112
2019
191
191
2020
139
139
2021
147
147
2022
139
139
2023
163
163
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
453
453
False Negative Result
321
321
High Test Results
210
210
Adverse Event Without Identified Device or Use Problem
120
120
No Apparent Adverse Event
112
112
Low Test Results
86
86
Incorrect, Inadequate or Imprecise Result or Readings
81
81
Incorrect Or Inadequate Test Results
78
78
Non Reproducible Results
15
15
Nonstandard Device
7
7
Detachment Of Device Component
7
7
Use of Incorrect Control/Treatment Settings
7
7
Incorrect Measurement
5
5
Leak/Splash
3
3
Improper or Incorrect Procedure or Method
3
3
High Readings
3
3
Device Operates Differently Than Expected
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Mechanical Problem
2
2
False Device Output
2
2
False Reading From Device Non-Compliance
1
1
Disconnection
1
1
Electrical /Electronic Property Problem
1
1
Contamination
1
1
Loose or Intermittent Connection
1
1
Product Quality Problem
1
1
Unexpected Therapeutic Results
1
1
Naturally Worn
1
1
Device Displays Incorrect Message
1
1
Chemical Problem
1
1
Chemical Spillage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
734
734
No Clinical Signs, Symptoms or Conditions
508
508
No Consequences Or Impact To Patient
197
197
Insufficient Information
6
6
Test Result
6
6
Hepatitis
5
5
Venipuncture
2
2
Misdiagnosis
2
2
No Information
2
2
Missing Value Reason
1
1
Eye Injury
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories
II
Apr-15-2009
2
Abbott Laboratories, Inc
II
Mar-25-2013
3
Bio-Rad Laboratories
III
Oct-21-2013
4
Bio-Rad Laboratories
II
Sep-17-2012
5
Bio-Rad Laboratories
III
May-20-2010
6
Diasorin Inc.
II
Mar-22-2011
7
ORTHO-CLINICAL DIAGNOSTICS
II
Jan-03-2019
8
Ortho-Clinical Diagnostics
II
Dec-20-2013
9
Ortho-Clinical Diagnostics
III
Apr-23-2013
10
Ortho-Clinical Diagnostics, Inc.
II
Jan-19-2024
11
Siemens Healthcare Diagnostics, Inc
II
Oct-21-2014
12
Siemens Healthcare Diagnostics, Inc.
II
Feb-17-2023
13
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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