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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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 43 43
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Contamination of Device Ingredient or Reagent 15 15
False Negative Result 8 8
Device Ingredient or Reagent Problem 3 3
Device Markings/Labelling Problem 3 3
Microbial Contamination of Device 3 3
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inaccurate Information 1 1
Incorrect Measurement 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 97 97
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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