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TPLC
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Device
system, test, carcinoembryonic antigen
Product Code
DHX
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS AMERICA, INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DISGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
33
33
2016
22
22
2017
7
7
2018
20
20
2019
12
12
2020
14
14
2021
11
11
2022
12
12
2023
16
16
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
58
58
Low Test Results
51
51
No Apparent Adverse Event
17
17
Incorrect, Inadequate or Imprecise Result or Readings
12
12
False Negative Result
11
11
Adverse Event Without Identified Device or Use Problem
11
11
Incorrect Or Inadequate Test Results
7
7
Non Reproducible Results
5
5
False Reading From Device Non-Compliance
2
2
Incorrect Measurement
2
2
Mechanical Problem
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
85
85
No Clinical Signs, Symptoms or Conditions
46
46
No Consequences Or Impact To Patient
25
25
No Code Available
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Test Result
1
1
No Information
1
1
Missing Value Reason
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Nov-06-2015
2
BioCheck Inc
II
Mar-11-2011
3
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
4
Tosoh Bioscience Inc
II
Jun-05-2018
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