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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, selective and differential
Product CodeJSI
Regulation Number 866.2360
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 5 5
2019 2 2
2020 5 5
2021 83 83
2022 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 53 53
Contamination 44 44
Contamination of Device Ingredient or Reagent 17 17
False Negative Result 14 14
Device Markings/Labelling Problem 5 5
Missing Information 3 3
Microbial Contamination of Device 3 3
Incorrect Or Inadequate Test Results 3 3
False Positive Result 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
No Patient Involvement 8 8
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 5 5
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Itching Sensation 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumedia Manufacturers, Inc. III Oct-26-2018
2 Acumedia Manufacturers, Inc. II Jun-14-2017
3 Acumedia Manufacturers, Inc. III Jun-02-2017
4 Remel Inc II Jan-14-2021
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