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TPLC
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show TPLC since
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Device
diluent, blood cell
Product Code
GIF
Regulation Number
864.8200
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
124
124
2015
2
2
2021
1
1
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
109
109
Device Operates Differently Than Expected
108
108
High Test Results
13
13
Device Ingredient or Reagent Problem
7
7
Device Displays Incorrect Message
4
4
Incorrect Or Inadequate Test Results
2
2
Operating System Becomes Nonfunctional
1
1
Output above Specifications
1
1
Contamination /Decontamination Problem
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
70
70
No Consequences Or Impact To Patient
57
57
Not Applicable
7
7
No Clinical Signs, Symptoms or Conditions
1
1
Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Aug-28-2015
2
Beckman Coulter Inc.
II
May-15-2015
3
Beckman Coulter Inc.
II
Sep-16-2014
4
Beckman Coulter, Inc.
II
Jul-12-2023
5
Mindray DS USA, Inc. dba Mindray North America
II
Apr-09-2018
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