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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 56 56
2023 16 16
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 61 61
Contamination 44 44
Contamination of Device Ingredient or Reagent 15 15
False Negative Result 8 8
Device Markings/Labelling Problem 5 5
Device Ingredient or Reagent Problem 4 4
Microbial Contamination of Device 4 4
Incorrect Measurement 1 1
Delivered as Unsterile Product 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Packaging Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 123 123
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
2 Becton Dickinson & Co. II Jul-24-2013
3 Hardy Diagnostics II Apr-26-2016
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