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TPLC
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show TPLC since
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2024
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Device
system, detection, bacterial, for platelet transfusion products
Product Code
MZC
Regulation Number
866.2560
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECTON, DICKINSON & COMPANY
SUBSTANTIALLY EQUIVALENT
2
BIOMERIEUX, INC.
SUBSTANTIALLY EQUIVALENT
3
IMMUNETICS, INC.
SUBSTANTIALLY EQUIVALENT
3
PALL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
VERAX BIOMEDICAL INCORPORATED
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
1
1
2016
9
9
2017
4
4
2018
7
7
2019
13
13
2021
8
8
2022
6
6
2023
2
2
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
24
24
False Positive Result
20
20
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Incorrect Or Inadequate Test Results
2
2
Insufficient Information
2
2
Missing Information
2
2
Contamination /Decontamination Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Improper or Incorrect Procedure or Method
1
1
Fluid/Blood Leak
1
1
Contamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
18
18
No Known Impact Or Consequence To Patient
14
14
No Patient Involvement
6
6
Fever
5
5
Nausea
4
4
Bacterial Infection
3
3
Tachycardia
3
3
Vomiting
3
3
Chills
3
3
Reaction
3
3
No Consequences Or Impact To Patient
2
2
Death
2
2
Rash
2
2
Sepsis
2
2
Septic Shock
2
2
Dyspnea
1
1
Pain
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Laceration(s)
1
1
Complaint, Ill-Defined
1
1
Chest Tightness/Pressure
1
1
Respiratory Failure
1
1
Lethargy
1
1
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