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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, general nutrient broth
Product CodeJSC
Regulation Number 866.2350
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Contamination of Device Ingredient or Reagent 2 2
Device Markings/Labelling Problem 1 1
Appropriate Term/Code Not Available 1 1
Microbial Contamination of Device 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Conjunctivitis 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 bioMerieux, Inc. II Nov-17-2021
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