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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
LIOFILCHEM S.R.L.
  SUBSTANTIALLY EQUIVALENT 6
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 22

MDR Year MDR Reports MDR Events
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 46 86
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
Insufficient Information 3 30
No Consequences Or Impact To Patient 1 1

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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