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TPLC
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show TPLC since
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Device
dna probe, nucleic acid amplification, chlamydia
Product Code
MKZ
Regulation Number
866.3120
Device Class
1
Premarket Reviews
Manufacturer
Decision
BECTON DICKINSON & CO.
SUBSTANTIALLY EQUIVALENT
1
BECTON, DICKINSON & CO.
SUBSTANTIALLY EQUIVALENT
2
HOLOGIC, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE MOLECULAR SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
1
1
2016
1
1
2017
6
6
2018
3
3
2019
3
3
2020
7
7
2021
9
9
2022
2
2
2023
4
4
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
7
7
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Adverse Event Without Identified Device or Use Problem
6
6
False Positive Result
5
5
Insufficient Information
4
4
Break
4
4
Use of Device Problem
3
3
Incorrect Or Inadequate Test Results
2
2
Off-Label Use
2
2
Appropriate Term/Code Not Available
2
2
Improper or Incorrect Procedure or Method
2
2
Difficult to Remove
1
1
Material Integrity Problem
1
1
Detachment Of Device Component
1
1
Malposition of Device
1
1
Volume Accuracy Problem
1
1
False Reading From Device Non-Compliance
1
1
Data Problem
1
1
Fracture
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
No Consequences Or Impact To Patient
6
6
Foreign Body In Patient
5
5
No Known Impact Or Consequence To Patient
3
3
Obstruction/Occlusion
2
2
Chemical Exposure
2
2
Nasal Obstruction
2
2
Sedation
2
2
Hypersensitivity/Allergic reaction
1
1
Complaint, Ill-Defined
1
1
Red Eye(s)
1
1
No Code Available
1
1
Test Result
1
1
Swelling
1
1
Vomiting
1
1
Numbness
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Reaction
1
1
Toxicity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Jun-24-2011
2
Becton Dickinson & Co.
II
Mar-03-2010
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