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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 SA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 15
BIOMÉRIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 14
COPAN WASP S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SELUX DIAGNOSTICS, INC
  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 180 180
2023 251 251

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1271 1271
False Positive Result 191 191
Incorrect Or Inadequate Test Results 66 66
Mechanical Problem 21 21
Computer Software Problem 19 19
Contamination 18 18
False Negative Result 15 15
Low Test Results 13 13
Missing Test Results 11 11
Device Markings/Labelling Problem 10 10
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
Failure to Back-Up 4 4
Leak/Splash 3 3
Data Back-Up Problem 3 3
Loss of Data 3 3
Unable to Obtain Readings 3 3
Device Contamination with Chemical or Other Material 3 3
Insufficient Information 2 2
Patient Data Problem 2 2
Application Program Problem 2 2
Expiration Date Error 2 2
Electrical /Electronic Property Problem 2 2
Microbial Contamination of Device 2 2
No Device Output 2 2
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Incomplete or Missing Packaging 1 1
Cross Reactivity 1 1
Decreased Sensitivity 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
High Test Results 1 1
Smoking 1 1
High Readings 1 1
Device Ingredient or Reagent Problem 1 1
Data Problem 1 1
Adverse Event Without Identified Device or Use 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

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 623 623
No Consequences Or Impact To Patient 319 319
No Patient Involvement 95 95
Misdiagnosis 19 19
Insufficient Information 13 13
Drug Resistant Bacterial Infection 2 2
Test Result 1 1
Localized Skin Lesion 1 1
Chemical Exposure 1 1
Bacterial Infection 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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