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TPLC
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Device
stains, microbiologic
Product Code
JTS
Regulation Number
864.1850
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
106
106
2021
4
4
2023
5
5
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
42
42
Device Contamination with Chemical or Other Material
35
35
Signal Artifact/Noise
21
21
False Positive Result
19
19
Precipitate in Device or Device Ingredient
13
13
Device Markings/Labelling Problem
7
7
Image Display Error/Artifact
6
6
Contamination /Decontamination Problem
5
5
Expiration Date Error
3
3
Clumping in Device or Device Ingredient
2
2
Defective Device
2
2
Leak/Splash
1
1
Off-Label Use
1
1
Therapeutic or Diagnostic Output Failure
1
1
Contamination
1
1
Moisture Damage
1
1
Missing Information
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
78
78
No Clinical Signs, Symptoms or Conditions
21
21
No Consequences Or Impact To Patient
12
12
Test Result
9
9
No Code Available
5
5
Therapeutic Effects, Unexpected
4
4
Bacterial Infection
2
2
No Patient Involvement
2
2
Fungus
1
1
Abrasion
1
1
Discomfort
1
1
Fungal Infection
1
1
Chemical Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
May-19-2020
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