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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
63
38
MDR Year
MDR Reports
MDR Events
2019
191
191
2020
139
139
2021
147
147
2022
139
139
2023
163
163
2024
131
131
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
349
349
False Negative Result
255
255
High Test Results
165
165
No Apparent Adverse Event
94
94
Low Test Results
43
43
Incorrect, Inadequate or Imprecise Result or Readings
34
34
Non Reproducible Results
21
21
Leak/Splash
3
3
Appropriate Term/Code Not Available
2
2
Improper or Incorrect Procedure or Method
2
2
Chemical Problem
1
1
Insufficient Information
1
1
High Readings
1
1
Incorrect Measurement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
582
582
No Known Impact Or Consequence To Patient
271
271
No Consequences Or Impact To Patient
55
55
Insufficient Information
6
6
Hepatitis
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
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
Jun-13-2024
3
Ortho-Clinical Diagnostics, Inc.
II
Jan-19-2024
4
Siemens Healthcare Diagnostics, Inc.
II
Feb-17-2023
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