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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
Product CodeJTZ
Regulation Number 866.1700
Device Class 2

MDR Year MDR Reports MDR Events
2021 20 20
2022 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 17 17
Incorrect, Inadequate or Imprecise Resultor Readings 15 15
Contamination of Device Ingredient or Reagent 7 7
Microbial Contamination of Device 3 3
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
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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