Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 & CO.
  SUBSTANTIALLY EQUIVALENT 3
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 9
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON,DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX SA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 21
BIOMÉRIEUX, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 50
COPAN WASP S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SELUX DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
SELUX DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 41 41
2016 94 97
2017 197 197
2018 512 512
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 1752 1755
Incorrect Or Inadequate Test Results 209 209
False Positive Result 206 206
Mechanical Problem 21 21
False Negative Result 21 21
Computer Software Problem 20 20
Contamination 18 18
Low Test Results 17 17
Device Markings/Labelling Problem 13 13
Missing Test Results 13 13
Use of Device Problem 11 11
Contamination of Device Ingredient or Reagent 11 11
Improper or Incorrect Procedure or Method 10 10
Incorrect Measurement 9 9
Output Problem 7 7
Communication or Transmission Problem 5 5
Device Operates Differently Than Expected 4 4
Smoking 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Back-Up 4 4
Device Contamination with Chemical or Other Material 4 4
Patient Data Problem 4 4
Leak/Splash 3 3
Microbial Contamination of Device 3 3
Unable to Obtain Readings 3 3
Device Damaged Prior to Use 3 3
Data Back-Up Problem 3 3
Electrical /Electronic Property Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Product Quality Problem 3 3
Loss of Data 3 3
Device Ingredient or Reagent Problem 2 2
Expiration Date Error 2 2
Fire 2 2
High Test Results 2 2
Insufficient Information 2 2
No Device Output 2 2
Failure to Obtain Sample 2 2
Application Program Problem 2 2
Unsealed Device Packaging 1 1
Incomplete or Missing Packaging 1 1
Device Packaging Compromised 1 1
Inaccurate Information 1 1
Device Issue 1 1
Incorrect Device Or Component Shipped 1 1
Packaging Problem 1 1
Cross Reactivity 1 1
Difficult to Insert 1 1
Decreased Sensitivity 1 1
Device Displays Incorrect Message 1 1
High Readings 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Program or Algorithm Execution Failure 1 1
Device Operational Issue 1 1
Illegible Information 1 1
Physical Resistance 1 1
Sparking 1 1
Display Difficult to Read 1 1
Device Inoperable 1 1
Battery Problem 1 1
Data Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 952 952
No Known Impact Or Consequence To Patient 775 775
No Consequences Or Impact To Patient 455 458
No Patient Involvement 135 135
Misdiagnosis 44 44
Insufficient Information 16 16
Test Result 4 4
Death 4 4
Bacterial Infection 3 3
Drug Resistant Bacterial Infection 2 2
Not Applicable 2 2
No Information 2 2
No Code Available 1 1
Localized Skin Lesion 1 1
Therapeutic Response, Decreased 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Premature Labor 1 1
Chemical Exposure 1 1
Diarrhea 1 1
Unspecified Infection 1 1
Inflammation 1 1
Laceration(s) 1 1
Sepsis 1 1
Therapeutic Effects, Unexpected 1 1
Toxic Shock Syndrome 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 Becton Dickinson & Co. II Nov-25-2017
6 Becton Dickinson & Co. III Oct-25-2016
7 Becton Dickinson & Co. II Dec-19-2012
8 Becton Dickinson & Co. II May-24-2012
9 Becton Dickinson & Co. II Mar-30-2011
10 Becton Dickinson & Co. II Nov-15-2010
11 BioMerieux SA II Jun-12-2018
12 Biomerieux Inc II Jan-04-2023
13 Biomerieux Inc II Mar-25-2021
14 Biomerieux Inc II Aug-25-2017
15 Biomerieux Inc II May-22-2017
16 Biomerieux Inc II May-03-2016
17 Biomerieux Inc I Apr-27-2011
18 Biomerieux Inc I Nov-11-2010
19 Biomerieux Inc II Aug-27-2010
20 Organon Teknika Inc II Feb-27-2019
21 Remel Inc. II May-08-2020
22 Siemens Healthcare Diagnostics, Inc. I Nov-07-2014
23 Siemens Healthcare Diagnostics, Inc. I Sep-11-2013
24 Siemens Microscan II Feb-04-2009
25 bioMerieux, Inc. II May-11-2022
26 bioMerieux, Inc. II Apr-12-2019
27 bioMerieux, Inc. II Feb-16-2019
28 bioMerieux, Inc. II Dec-19-2018
29 bioMerieux, Inc. II Dec-17-2018
30 bioMerieux, Inc. I Aug-30-2018
-
-