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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device manual antimicrobial susceptibility test systems
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMÉRIEUX S.A.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 7
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 22
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 14

MDR Year MDR Reports MDR Events
2017 9 9
2018 13 13
2019 10 10
2020 20 20
2021 41 41
2022 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 80 80
Incorrect Or Inadequate Test Results 15 15
Low Test Results 5 5
Protective Measures Problem 1 1
Insufficient Information 1 1
Volume Accuracy Problem 1 1
False Reading From Device Non-Compliance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
No Known Impact Or Consequence To Patient 33 33
No Patient Involvement 13 13
No Consequences Or Impact To Patient 6 6
Insufficient Information 2 2
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-02-2018
2 BioMerieux SA II Dec-19-2017
3 BioMerieux SA II May-03-2017
4 BioMerieux SA II May-03-2017
5 BioMerieux SA II Mar-21-2017
6 BioMerieux SA II Feb-21-2017
7 Biomerieux Inc II Aug-06-2021
8 Remel Inc II Mar-04-2022
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