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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
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX S.A.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA
  SUBSTANTIALLY EQUIVALENT 6
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 7
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 13

MDR Year MDR Reports MDR Events
2019 10 10
2020 20 20
2021 41 41
2022 11 11
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 75 75
High Test Results 8 8
Low Test Results 7 7
Protective Measures Problem 1 1
Component Misassembled 1 1
Volume Accuracy Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 8 8
No Consequences Or Impact To Patient 4 4
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II Aug-06-2021
3 Remel Inc I Dec-08-2022
4 Remel Inc II Mar-04-2022
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