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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, excluding mueller hinton agar
Product CodeJSO
Regulation Number 866.1700
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 1
HARDY DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
REMEL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 14 14
2019 9 9
2020 7 7
2021 27 27
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 46 46
Incorrect Or Inadequate Test Results 25 25
False Positive Result 21 21
False Negative Result 6 6
Defective Device 3 3
Contamination of Device Ingredient or Reagent 2 2
Contamination 2 2
Material Discolored 1 1
Nonstandard Device 1 1
Device Markings/Labelling Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 42 42
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 22 22
No Patient Involvement 11 11
Misdiagnosis 4 4
Drug Resistant Bacterial Infection 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Mar-09-2018
2 Becton Dickinson & Co. II Dec-06-2017
3 Bio-Rad Laboratories, Inc II Jun-06-2019
4 Hardy Diagnostics II Jan-25-2021
5 Hardy Diagnostics II Jun-09-2020
6 Remel Inc II May-12-2021
7 Remel Inc II Apr-13-2021
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