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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
2020 5 5
2021 83 83
2022 88 88
2023 36 36
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 110 110
Contamination 63 63
Contamination of Device Ingredient or Reagent 24 24
False Negative Result 15 15
Device Markings/Labelling Problem 8 8
Microbial Contamination of Device 4 4
Device Contamination with Chemical or Other Material 4 4
False Positive Result 4 4
Missing Information 3 3
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 228 228
No Known Impact Or Consequence To Patient 4 4
No Patient Involvement 3 3
No Consequences Or Impact To Patient 3 3
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Itching Sensation 1 1
Insufficient Information 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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