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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
Product CodeJSJ
Regulation Number 866.2360
Device Class 1

MDR Year MDR Reports MDR Events
2018 2 2
2019 10 10
2020 6 6
2021 46 46
2022 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 41 41
Incorrect, Inadequate or Imprecise Resultor Readings 35 35
Contamination of Device Ingredient or Reagent 15 15
False Negative Result 8 8
Microbial Contamination of Device 3 3
Device Markings/Labelling Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inaccurate Information 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 83
No Known Impact Or Consequence To Patient 13 13
No Consequences Or Impact To Patient 7 7
No Patient Involvement 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumedia Manufacturers, Inc. III Oct-26-2018
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