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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 99 99
Contamination 63 63
Contamination of Device Ingredient or Reagent 24 24
False Negative Result 12 12
Device Markings/Labelling Problem 7 7
Microbial Contamination of Device 4 4
Device Contamination with Chemical or Other Material 4 4
Missing Information 3 3
False Positive Result 2 2
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 208 208
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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