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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
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Contamination
39
39
Incorrect, Inadequate or Imprecise Resultor Readings
35
35
Contamination of Device Ingredient or Reagent
15
15
False Negative Result
8
8
Microbial Contamination of Device
2
2
Device Markings/Labelling Problem
2
2
Device Contaminated During Manufacture or Shipping
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Inaccurate Information
1
1
Delivered as Unsterile Product
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
80
80
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
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