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TPLC
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Device
system, test, immunological, antigen, tumor
Regulation Description
Tumor-associated antigen immunological test system.
Product Code
MOI
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
FUJIREBIO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
11
11
2021
16
16
2022
16
16
2023
6
6
2024
5
5
2025
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
28
28
Low Test Results
18
18
No Apparent Adverse Event
6
6
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Non Reproducible Results
3
3
High Readings
2
2
Mechanical Problem
1
1
Imprecision
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
48
48
No Known Impact Or Consequence To Patient
9
9
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Healthcare Diagnostics, Inc
II
Sep-03-2021
2
Siemens Healthcare Diagnostics, Inc.
II
Aug-29-2022
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