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TPLC
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show TPLC since
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Device
enzyme linked immunoabsorption assay, treponema pallidum
Product Code
LIP
Regulation Number
866.3830
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIO-RAD LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
3
3
2018
5
5
2019
9
9
2020
46
46
2021
54
54
2022
20
20
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
105
105
False Positive Result
13
13
Low Test Results
12
12
Adverse Event Without Identified Device or Use Problem
3
3
No Apparent Adverse Event
3
3
Off-Label Use
2
2
High Test Results
1
1
Leak/Splash
1
1
Component Misassembled
1
1
Unclear Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
68
68
No Known Impact Or Consequence To Patient
52
52
No Consequences Or Impact To Patient
12
12
Insufficient Information
3
3
No Code Available
2
2
Exposure to Body Fluids
1
1
Eye Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bio-Rad Laboratories, Inc.
II
May-16-2022
2
Bio-Rad Laboratories, Inc.
II
Mar-16-2022
3
Bio-Rad Laboratories, Inc.
II
Nov-16-2021
4
Bio-Rad Laboratories, Inc.
II
Sep-18-2020
5
Siemens Healthcare Diagnostics, Inc
II
May-24-2021
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