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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


Premarket Reviews
ManufacturerDecision
EDGE BIOLOGICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 20 20
2022 27 27
2023 20 20
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Contamination 22 22
Contamination of Device Ingredient or Reagent 8 8
Microbial Contamination of Device 3 3
Device Markings/Labelling Problem 2 2
Low pH 1 1
Illegible Information 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jun-21-2011
2 Remel Inc II Dec-07-2017
3 Remel, Inc II Jan-15-2010
4 Thermo Fisher II Jun-08-2018
5 Trek Diagnostic Systems III Sep-30-2009
6 Trek Diagnostic Systems II Jan-28-2009
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