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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device supplement, culture media
Product CodeJSK
Regulation Number 866.2450
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2021 6 6
2022 4 4
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Contamination 4 4
Leak/Splash 1 1
Unable to Obtain Readings 1 1
Microbial Contamination of Device 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Operates Differently Than Expected 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 3 3
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumedia Manufacturers, Inc. III Jun-01-2017
2 Remel Inc II Mar-02-2015
3 Remel Inc II Dec-12-2014
4 Remel Inc II Nov-10-2014
5 Remel Inc II Feb-26-2014
6 Remel Inc II Feb-11-2013
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