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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 non-differential
Regulation Description Selective culture medium.
Product CodeJSJ
Regulation Number 866.2360
Device Class 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 46 46
2022 56 56
2023 16 16
2024 19 19
2025 337 337

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 398 398
Contamination 48 48
Contamination of Device Ingredient or Reagent 15 15
Device Markings/Labelling Problem 6 6
Device Ingredient or Reagent Problem 4 4
Microbial Contamination of Device 3 3
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1
Incorrect Measurement 1 1
Device Contamination with Chemical or Other Material 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 474 474
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 4 4
No Patient Involvement 2 2

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