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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 & 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 11
BIOMÉRIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 18

MDR Year MDR Reports MDR Events
2017 197 197
2018 512 512
2019 315 315
2020 218 218
2021 232 232
2022 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 1028 1028
Incorrect Or Inadequate Test Results 193 193
False Positive Result 181 181
Mechanical Problem 21 21
Computer Software Problem 19 19
False Negative Result 14 14
Missing Test Results 13 13
Improper or Incorrect Procedure or Method 10 10
Use of Device Problem 10 10
Contamination 9 9
Contamination of Device Ingredient or Reagent 9 9
Incorrect Measurement 8 8
Output Problem 7 7
Communication or Transmission Problem 5 5
Failure to Back-Up 3 3
Smoking 3 3
Electrical /Electronic Property Problem 3 3
Unable to Obtain Readings 3 3
Device Damaged Prior to Use 3 3
Data Back-Up Problem 3 3
Device Markings/Labelling Problem 3 3
No Device Output 2 2
Insufficient Information 2 2
Loss of Data 2 2
Patient Data Problem 2 2
Expiration Date Error 2 2
Sparking 1 1
Fire 1 1
Unsealed Device Packaging 1 1
Device Operational Issue 1 1
Program or Algorithm Execution Failure 1 1
Inaccurate Information 1 1
Data Problem 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Low Test Results 1 1
Failure to Obtain Sample 1 1
Packaging Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
High Readings 1 1
Device Displays Incorrect Message 1 1
Cross Reactivity 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 272 272
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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