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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, test, automated, antimicrobial susceptibility, short incubation
Product CodeLON
Regulation Number 866.1645
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON,DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 12
BIOMÉRIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 13
COPAN WASP S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SELUX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 512 512
2019 315 315
2020 218 218
2021 232 232
2022 177 177

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1050 1050
False Positive Result 182 182
Incorrect Or Inadequate Test Results 66 66
Mechanical Problem 21 21
Computer Software Problem 19 19
Contamination 15 15
False Negative Result 12 12
Low Test Results 11 11
Missing Test Results 11 11
Contamination of Device Ingredient or Reagent 10 10
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Incorrect Measurement 8 8
Output Problem 7 7
Communication or Transmission Problem 5 5
Device Markings/Labelling Problem 4 4
Unable to Obtain Readings 3 3
Data Back-Up Problem 3 3
Failure to Back-Up 3 3
Electrical /Electronic Property Problem 2 2
No Device Output 2 2
Loss of Data 2 2
Application Program Problem 2 2
Expiration Date Error 2 2
Insufficient Information 2 2
Data Problem 1 1
Patient Data Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Program or Algorithm Execution Failure 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Decreased Sensitivity 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
High Readings 1 1
High Test Results 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Ingredient or Reagent Problem 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Smoking 1 1
Cross Reactivity 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 645 645
No Clinical Signs, Symptoms or Conditions 374 374
No Consequences Or Impact To Patient 319 319
No Patient Involvement 95 95
Misdiagnosis 19 19
Insufficient Information 9 9
Drug Resistant Bacterial Infection 2 2
Test Result 1 1
Chemical Exposure 1 1
Death 1 1
Unspecified Infection 1 1
Sepsis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Nov-14-2022
2 Becton Dickinson & Co. II Dec-31-2020
3 Becton Dickinson & Co. II Feb-23-2019
4 BioMerieux SA II Jun-12-2018
5 Biomerieux Inc II Jan-04-2023
6 Biomerieux Inc II Mar-25-2021
7 Organon Teknika Inc II Feb-27-2019
8 Remel Inc. II May-08-2020
9 bioMerieux, Inc. II May-11-2022
10 bioMerieux, Inc. II Apr-12-2019
11 bioMerieux, Inc. II Feb-16-2019
12 bioMerieux, Inc. II Dec-19-2018
13 bioMerieux, Inc. II Dec-17-2018
14 bioMerieux, Inc. I Aug-30-2018
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