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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, identification, enterobacteriaceae
Product CodeJSS
Regulation Number 866.2660
Device Class 1


Premarket Reviews
ManufacturerDecision
ADVANDX, INC.
  SUBSTANTIALLY EQUIVALENT 6
MIACOM DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 3 3
2018 3 3
2019 3 3
2020 8 8
2021 9 9
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Incorrect Or Inadequate Test Results 3 3
Incorrect Measurement 2 2
Unable to Obtain Readings 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 11 11
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AdvanDx, Inc. III Jan-02-2014
2 AdvanDx, Inc. II Dec-01-2010
3 AdvanDx, Inc. II Nov-29-2010
4 Advandx Inc II Oct-22-2012
5 Advandx Inc II Oct-22-2012
6 Becton Dickinson & Co. III Jul-11-2014
7 Becton Dickinson & Co. II Jan-20-2013
8 Biomerieux Inc II Jan-04-2023
9 Biomerieux Inc II Dec-27-2021
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