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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
2015 1 1
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
Device Contamination with Chemical or Other Material 1 1
Appropriate Term/Code Not Available 1 1
Microbial Contamination of Device 1 1
Leak/Splash 1 1
Particulates 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
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jan-25-2013
2 Becton Dickinson & Co. II Mar-23-2012
3 Hardy Diagnostics II Dec-23-2015
4 Remel, Inc II Mar-09-2010
5 bioMerieux, Inc. II Nov-17-2021
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