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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device positive blood culture identification and ast kit
Definition Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
Product CodePRH
Regulation Number 866.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCELERATE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCELERATE DIAGNOTICS
  GRANTED 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Adverse Event Without Identified Device or Use Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 1 1
Therapeutic Response, Increased 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accelerate Diagnostics Inc II Dec-06-2022
2 Accelerate Diagnostics Inc II Mar-27-2019
3 Accelerate Diagnostics Inc II Apr-26-2018
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