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TPLC
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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
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
46
46
2021
54
54
2022
44
44
2023
66
66
2024
46
46
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
232
232
False Positive Result
18
18
Low Test Results
10
10
Incorrect, Inadequate or Imprecise Result or Readings
3
3
No Apparent Adverse Event
3
3
Appropriate Term/Code Not Available
2
2
High Test Results
1
1
Off-Label Use
1
1
Non Reproducible Results
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
203
203
No Known Impact Or Consequence To Patient
45
45
No Consequences Or Impact To Patient
12
12
Insufficient Information
4
4
No Code Available
2
2
Exposure to Body Fluids
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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