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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
SIEMENS HEALTHCARE DISGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
20
20
2019
12
12
2020
14
14
2021
11
11
2022
12
12
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
34
34
No Apparent Adverse Event
17
17
High Test Results
13
13
Non Reproducible Results
3
3
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Incorrect Or Inadequate Test Results
1
1
False Negative Result
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
33
33
No Clinical Signs, Symptoms or Conditions
22
22
No Consequences Or Impact To Patient
11
11
No Code Available
3
3
Missing Value Reason
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
2
Tosoh Bioscience Inc
II
Jun-05-2018
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