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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 & COMPANY
  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 19

MDR Year MDR Reports MDR Events
2017 197 197
2018 512 512
2019 315 315
2020 218 218
2021 232 232
2022 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 1066 1066
Incorrect Or Inadequate Test Results 193 193
False Positive Result 183 183
Mechanical Problem 21 21
Computer Software Problem 19 19
False Negative Result 14 14
Missing Test Results 13 13
Contamination 11 11
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Contamination of Device Ingredient or Reagent 10 10
Incorrect Measurement 8 8
Output Problem 7 7
Communication or Transmission Problem 5 5
Unable to Obtain Readings 3 3
Data Back-Up Problem 3 3
Device Markings/Labelling Problem 3 3
Failure to Back-Up 3 3
Electrical /Electronic Property Problem 3 3
Device Damaged Prior to Use 3 3
Smoking 3 3
No Device Output 2 2
Loss of Data 2 2
Insufficient Information 2 2
Expiration Date Error 2 2
Patient Data Problem 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Program or Algorithm Execution Failure 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Failure to Obtain Sample 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Low Test Results 1 1
High Readings 1 1
Data Problem 1 1
Packaging Problem 1 1
Device Operational Issue 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Cross Reactivity 1 1
Fire 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 731 731
No Consequences Or Impact To Patient 380 380
No Clinical Signs, Symptoms or Conditions 317 317
No Patient Involvement 127 127
Misdiagnosis 37 37
Insufficient Information 2 2
Test Result 1 1
No Information 1 1
Drug Resistant Bacterial Infection 1 1
Death 1 1
Unspecified Infection 1 1
Needle Stick/Puncture 1 1
Premature Labor 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-31-2020
2 Becton Dickinson & Co. II Feb-23-2019
3 Becton Dickinson & Co. II Nov-25-2017
4 BioMerieux SA II Jun-12-2018
5 Biomerieux Inc II Mar-25-2021
6 Biomerieux Inc II Aug-25-2017
7 Biomerieux Inc II May-22-2017
8 Organon Teknika Inc II Feb-27-2019
9 Remel Inc. II May-08-2020
10 bioMerieux, Inc. II May-11-2022
11 bioMerieux, Inc. II Apr-12-2019
12 bioMerieux, Inc. II Feb-16-2019
13 bioMerieux, Inc. II Dec-19-2018
14 bioMerieux, Inc. II Dec-17-2018
15 bioMerieux, Inc. I Aug-30-2018
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