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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
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 16
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2018 13 13
2019 10 10
2020 20 20
2021 41 41
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 80 80
Incorrect Or Inadequate Test Results 8 8
Low Test Results 5 5
High Test Results 2 2
Volume Accuracy Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
No Known Impact Or Consequence To Patient 30 30
No Patient Involvement 10 10
No Consequences Or Impact To Patient 4 4
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Oct-02-2018
2 Biomerieux Inc II Jan-04-2023
3 Biomerieux Inc II Aug-06-2021
4 Remel Inc II Mar-04-2022
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