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TPLC
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Device
system, test, immunological, antigen, tumor
Product Code
MOI
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
FUJIREBIO DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1
1
2019
5
5
2020
11
11
2021
16
16
2022
16
16
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
22
22
Low Test Results
13
13
No Apparent Adverse Event
10
10
Incorrect, Inadequate or Imprecise Result or Readings
4
4
High Readings
2
2
Non Reproducible Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
35
35
No Known Impact Or Consequence To Patient
14
14
No Consequences Or Impact To Patient
1
1
No Patient Involvement
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
3
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
4
Tosoh Bioscience Inc
II
Jun-05-2018
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