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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)
2019
2020
2021
2022
2023
2024
36
53
60
70
64
10
MDR Year
MDR Reports
MDR Events
2019
191
191
2020
139
139
2021
147
147
2022
139
139
2023
163
163
2024
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
312
312
False Negative Result
224
224
High Test Results
147
147
No Apparent Adverse Event
94
94
Low Test Results
36
36
Incorrect, Inadequate or Imprecise Result or Readings
27
27
Non Reproducible Results
12
12
Leak/Splash
3
3
Improper or Incorrect Procedure or Method
2
2
Incorrect Measurement
1
1
High Readings
1
1
Chemical Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
487
487
No Known Impact Or Consequence To Patient
271
271
No Consequences Or Impact To Patient
55
55
Insufficient Information
6
6
Hepatitis
4
4
Vomiting
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ORTHO-CLINICAL DIAGNOSTICS
II
Jan-03-2019
2
Ortho-Clinical Diagnostics, Inc.
II
Jan-19-2024
3
Siemens Healthcare Diagnostics, Inc.
II
Feb-17-2023
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