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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
2019 2 2
2020 5 5
2021 83 83
2022 88 88
2023 36 36
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 101 101
Contamination 63 63
Contamination of Device Ingredient or Reagent 24 24
False Negative Result 15 15
Device Markings/Labelling Problem 7 7
Device Contamination with Chemical or Other Material 4 4
Microbial Contamination of Device 4 4
False Positive Result 3 3
Missing Information 3 3
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 214 214
No Patient Involvement 5 5
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Insufficient Information 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Remel Inc II Jan-14-2021
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