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TPLC
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show TPLC since
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Device
instrument, coagulation, automated
Product Code
GKP
Regulation Number
864.5400
Device Class
2
Premarket Reviews
Manufacturer
Decision
INSTRUMENTATION LABORATORY COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
19
19
2019
38
38
2020
14
14
2021
17
17
2022
4
4
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
34
34
Low Test Results
13
13
High Test Results
12
12
Use of Device Problem
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Incorrect Or Inadequate Test Results
5
5
Improper or Incorrect Procedure or Method
3
3
Contamination /Decontamination Problem
3
3
Data Problem
2
2
Device Handling Problem
2
2
Smoking
1
1
Electrical /Electronic Property Problem
1
1
Flushing Problem
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
59
59
No Clinical Signs, Symptoms or Conditions
26
26
Therapeutic Response, Increased
4
4
Needle Stick/Puncture
4
4
Abrasion
2
2
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Instrumentation Laboratory
II
Sep-12-2023
2
Instrumentation Laboratory
II
Apr-28-2022
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