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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device culture media, antimicrobial susceptibility test, mueller hinton agar/broth
Regulation Description Culture medium for antimicrobial susceptibility tests.
Product CodeJTZ
Regulation Number 866.1700
Device Class 2

MDR Year MDR Reports MDR Events
2021 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Contamination 7 7
Contamination of Device Ingredient or Reagent 2 2
Microbial Contamination of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Remel Inc II Dec-07-2017
2 Thermo Fisher II Jun-08-2018
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