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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device culture media, non-selective and non-differential
Regulation Description Multipurpose culture medium.
Product CodeJSG
Regulation Number 866.2300
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 177 177
2022 198 198
2023 182 182
2024 32 32
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 246 246
Contamination 185 185
Device Markings/Labelling Problem 61 61
Contamination of Device Ingredient or Reagent 57 57
Microbial Contamination of Device 15 15
Device Contamination with Chemical or Other Material 9 9
Missing Information 6 6
Fluid/Blood Leak 3 3
Contamination /Decontamination Problem 2 2
Product Quality Problem 2 2
Leak/Splash 1 1
Separation Problem 1 1
False Negative Result 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Missing 1 1
Particulates 1 1
Connection Problem 1 1
Inaccurate Information 1 1
False Positive Result 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 578 578
No Consequences Or Impact To Patient 11 11
No Patient Involvement 7 7
Insufficient Information 4 4
Needle Stick/Puncture 1 1
Prolapse 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Vectornate USA Inc II Apr-13-2021
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