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TPLC
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show TPLC since
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Device
culture media, selective and non-differential
Product Code
JSJ
Regulation Number
866.2360
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
2
2
2019
10
10
2020
6
6
2021
46
46
2022
56
56
2023
16
16
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
61
61
Contamination
44
44
Contamination of Device Ingredient or Reagent
15
15
False Negative Result
8
8
Device Markings/Labelling Problem
5
5
Device Ingredient or Reagent Problem
4
4
Microbial Contamination of Device
4
4
Incorrect Measurement
1
1
Delivered as Unsterile Product
1
1
Device Contamination with Chemical or Other Material
1
1
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Packaging Problem
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
123
123
No Known Impact Or Consequence To Patient
13
13
No Consequences Or Impact To Patient
7
7
No Patient Involvement
2
2
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acumedia Manufacturers, Inc.
III
Oct-26-2018
2
Becton Dickinson & Co.
II
Jul-24-2013
3
Hardy Diagnostics
II
Apr-26-2016
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