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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
BIOMERIEUX SA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 15
BIOMÉRIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 15
COPAN WASP S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SELUX DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
SELUX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 315 315
2020 218 218
2021 232 232
2022 180 180
2023 453 453
2024 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1162 1162
False Positive Result 183 183
Mechanical Problem 21 21
Computer Software Problem 19 19
Contamination 18 18
False Negative Result 14 14
Low Test Results 13 13
Device Markings/Labelling Problem 13 13
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 9 9
Output Problem 7 7
Communication or Transmission Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Loss of Data 3 3
Leak/Splash 3 3
Microbial Contamination of Device 3 3
No Device Output 2 2
Electrical /Electronic Property Problem 2 2
Device Ingredient or Reagent Problem 2 2
Patient Data Problem 2 2
Insufficient Information 2 2
Expiration Date Error 2 2
Unable to Obtain Readings 2 2
Application Program Problem 2 2
Decreased Sensitivity 1 1
Sparking 1 1
High Readings 1 1
Smoking 1 1
Data Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Back-Up 1 1
Cross Reactivity 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Incomplete or Missing Packaging 1 1
High Test Results 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 Clinical Signs, Symptoms or Conditions 950 950
No Known Impact Or Consequence To Patient 409 409
No Consequences Or Impact To Patient 111 111
No Patient Involvement 33 33
Misdiagnosis 15 15
Insufficient Information 15 15
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 Mar-29-2024
2 Becton Dickinson & Co. II Nov-14-2022
3 Becton Dickinson & Co. II Dec-31-2020
4 Becton Dickinson & Co. II Feb-23-2019
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
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