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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)
2020
2021
2022
2023
2024
2025
53
60
70
63
52
7
MDR Year
MDR Reports
MDR Events
2020
139
139
2021
147
147
2022
139
139
2023
163
163
2024
201
201
2025
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
328
328
False Negative Result
256
256
High Test Results
156
156
Low Test Results
52
52
Non Reproducible Results
23
23
No Apparent Adverse Event
22
22
Incorrect, Inadequate or Imprecise Result or Readings
18
18
Leak/Splash
3
3
Insufficient Information
3
3
Improper or Incorrect Procedure or Method
2
2
Appropriate Term/Code Not Available
2
2
Incorrect Measurement
2
2
Device Contamination with Body Fluid
1
1
Chemical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
666
666
No Known Impact Or Consequence To Patient
103
103
No Consequences Or Impact To Patient
35
35
Insufficient Information
6
6
Hepatitis
1
1
Vomiting
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics, Inc.
II
Jun-13-2024
2
Ortho-Clinical Diagnostics, Inc.
II
Jan-19-2024
3
Siemens Healthcare Diagnostics, Inc.
II
Feb-17-2023
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