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TPLC
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show TPLC since
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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)
2018
2019
2020
2021
2022
2023
73
36
53
60
70
22
MDR Year
MDR Reports
MDR Events
2018
112
112
2019
191
191
2020
139
139
2021
147
147
2022
139
139
2023
111
111
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
296
296
False Negative Result
196
196
High Test Results
159
159
No Apparent Adverse Event
112
112
Low Test Results
52
52
Incorrect, Inadequate or Imprecise Result or Readings
34
34
Adverse Event Without Identified Device or Use Problem
13
13
Non Reproducible Results
12
12
Incorrect Or Inadequate Test Results
10
10
Leak/Splash
3
3
Improper or Incorrect Procedure or Method
2
2
Incorrect Measurement
1
1
High Readings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
399
399
No Known Impact Or Consequence To Patient
361
361
No Consequences Or Impact To Patient
76
76
Insufficient Information
6
6
Hepatitis
5
5
Vomiting
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ORTHO-CLINICAL DIAGNOSTICS
II
Jan-03-2019
2
Siemens Healthcare Diagnostics, Inc.
II
Feb-17-2023
3
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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