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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 & 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 257 257

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1866 1869
Incorrect Or Inadequate Test Results 209 209
False Positive Result 208 208
Mechanical Problem 21 21
False Negative Result 21 21
Computer Software Problem 20 20
Contamination 18 18
Low Test Results 17 17
Missing Test Results 13 13
Device Markings/Labelling Problem 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
Patient Data Problem 4 4
Failure to Back-Up 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Leak/Splash 3 3
Data Back-Up Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Microbial Contamination of Device 3 3
Unable to Obtain Readings 3 3
Electrical /Electronic Property Problem 3 3
Loss of Data 3 3
Device Damaged Prior to Use 3 3
Product Quality Problem 3 3
High Test Results 2 2
Insufficient Information 2 2
Application Program Problem 2 2
Fire 2 2
No Device Output 2 2
Failure to Obtain Sample 2 2
Expiration Date Error 2 2
Device Ingredient or Reagent Problem 2 2
Display Difficult to Read 1 1
Decreased Sensitivity 1 1
Illegible Information 1 1
Device Operational Issue 1 1
Program or Algorithm Execution Failure 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Device Packaging Compromised 1 1
Device Displays Incorrect Message 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1078 1078
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 18 18
Death 4 4
Test Result 4 4
Bacterial Infection 3 3
Drug Resistant Bacterial Infection 2 2
Not Applicable 2 2
No Information 2 2
Unspecified Infection 1 1
Sepsis 1 1
No Code Available 1 1
Inflammation 1 1
Chemical Exposure 1 1
Localized Skin Lesion 1 1
Injury 1 1
Needle Stick/Puncture 1 1
Diarrhea 1 1
Laceration(s) 1 1
Toxic Shock Syndrome 1 1
Therapeutic Response, Decreased 1 1
Therapeutic Effects, Unexpected 1 1
Premature Labor 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 I Apr-25-2024
13 Biomerieux Inc II Jan-04-2023
14 Biomerieux Inc II Mar-25-2021
15 Biomerieux Inc II Aug-25-2017
16 Biomerieux Inc II May-22-2017
17 Biomerieux Inc II May-03-2016
18 Biomerieux Inc I Apr-27-2011
19 Biomerieux Inc I Nov-11-2010
20 Biomerieux Inc II Aug-27-2010
21 Organon Teknika Inc II Feb-27-2019
22 Remel Inc. II May-08-2020
23 Siemens Healthcare Diagnostics, Inc. I Nov-07-2014
24 Siemens Healthcare Diagnostics, Inc. I Sep-11-2013
25 Siemens Microscan II Feb-04-2009
26 bioMerieux, Inc. II May-11-2022
27 bioMerieux, Inc. II Apr-12-2019
28 bioMerieux, Inc. II Feb-16-2019
29 bioMerieux, Inc. II Dec-19-2018
30 bioMerieux, Inc. II Dec-17-2018
31 bioMerieux, Inc. I Aug-30-2018
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