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TPLC
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show TPLC since
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Device
clinical sample concentrator
Product Code
JJH
Regulation Number
862.2310
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
12
12
2021
20
20
2022
45
45
2023
10
10
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Suction Failure
21
21
Unintended Movement
10
10
False Positive Result
10
10
Fluid/Blood Leak
9
9
Contamination
9
9
Leak/Splash
6
6
Improper or Incorrect Procedure or Method
4
4
Contamination /Decontamination Problem
4
4
Contamination of Device Ingredient or Reagent
4
4
Low Sensing Threshold
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Use of Device Problem
3
3
Failure to Transmit Record
2
2
Mechanical Problem
2
2
Electrical /Electronic Property Problem
2
2
False Negative Result
2
2
Human-Device Interface Problem
2
2
Device Fell
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Pressure Problem
2
2
Mechanics Altered
1
1
Device Dislodged or Dislocated
1
1
Failure to Back-Up
1
1
Break
1
1
Unable to Obtain Readings
1
1
Failure to Read Input Signal
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of Device
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
79
79
No Known Impact Or Consequence To Patient
7
7
Abrasion
3
3
Misdiagnosis
3
3
Chemical Exposure
3
3
No Patient Involvement
2
2
Injury
2
2
Dizziness
1
1
No Consequences Or Impact To Patient
1
1
Exposure to Body Fluids
1
1
Bone Fracture(s)
1
1
Laceration(s)
1
1
Nausea
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Aug-22-2019
2
Entopsis , Inc.
II
Mar-29-2023
3
Qiagen Sciences LLC
II
Apr-10-2024
4
Qiagen Sciences LLC
II
Sep-15-2022
5
Qiagen Sciences LLC
II
Aug-21-2019
6
Qiagen Sciences LLC
I
Aug-01-2019
7
Qvella Corporation
II
Dec-07-2022
8
Roche Molecular Systems, Inc.
II
Jul-10-2020
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