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TPLC
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show TPLC since
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2024
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Device
system, test, immunological, antigen, tumor
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
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
52
52
2015
28
28
2016
5
5
2017
7
7
2018
1
1
2019
5
5
2020
11
11
2021
16
16
2022
16
16
2023
6
6
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
44
44
Low Test Results
22
22
Incorrect Or Inadequate Test Results
18
18
Component Falling
14
14
Incorrect, Inadequate or Imprecise Result or Readings
11
11
No Apparent Adverse Event
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Mechanical Problem
4
4
Non Reproducible Results
3
3
Smoking
3
3
Device Operates Differently Than Expected
3
3
Unintended Collision
3
3
False Negative Result
2
2
False Reading From Device Non-Compliance
2
2
Failure to Calibrate
2
2
High Readings
2
2
Device Ingredient or Reagent Problem
1
1
Patient Data Problem
1
1
Imprecision
1
1
Computer Operating System Problem
1
1
Calibration Problem
1
1
Nonstandard Device
1
1
Device Displays Incorrect Message
1
1
False Positive Result
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
71
71
No Clinical Signs, Symptoms or Conditions
41
41
No Consequences Or Impact To Patient
23
23
Head Injury
4
4
Swelling
2
2
Headache
2
2
Bruise/Contusion
2
2
No Code Available
1
1
No Information
1
1
Injury
1
1
Erythema
1
1
Concussion
1
1
No Patient Involvement
1
1
Tissue Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
May-12-2017
2
Siemens Healthcare Diagnostics, Inc
II
Sep-03-2021
3
Siemens Healthcare Diagnostics, Inc
II
Apr-06-2017
4
Siemens Healthcare Diagnostics, Inc
II
Dec-11-2012
5
Siemens Healthcare Diagnostics, Inc
II
Oct-28-2012
6
Siemens Healthcare Diagnostics, Inc.
II
Aug-29-2022
7
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
8
Tosoh Bioscience Inc
II
Jun-05-2018
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