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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
Regulation Description Antimicrobial susceptibility test powder.
Product CodeJWY
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMÉRIEUX
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX S.A.
  SUBSTANTIALLY EQUIVALENT 2
BIOMÉRIEUX SA
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. 1.
  SUBSTANTIALLY EQUIVALENT 1
LIOFILCHEM S. R. L.
  SUBSTANTIALLY EQUIVALENT 6
THERMOFISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 24

MDR Year MDR Reports MDR Events
2020 20 20
2021 41 41
2022 11 51
2023 9 9
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 66 106
High Test Results 8 8
Low Test Results 7 7
Volume Accuracy Problem 1 5
Material Integrity Problem 1 1
Component Misassembled 1 1
Protective Measures Problem 1 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 71
No Known Impact Or Consequence To Patient 11 11
No Patient Involvement 6 6
No Consequences Or Impact To Patient 4 4
Insufficient Information 3 30

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
5 Remel, Inc II Jun-11-2025
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