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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, blood culturing
Regulation Description Microbial growth monitor.
Product CodeMDB
Regulation Number 866.2560
Device Class 1


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 5
BECTON DICKINSON
  SUBSTANTIALLY EQUIVALENT 2
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON & CO.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
False Positive Result 274
Incorrect, Inadequate or Imprecise Result or Readings 265
Contamination During Use 117
False Negative Result 50
Incorrect Or Inadequate Test Results 20
Overheating of Device 15
Device Operates Differently Than Expected 15
Device Displays Incorrect Message 15
Device Markings / Labelling Problem 12
Fluid Leak 8
Crack 4
Leak / Splash 4
Date/Time-Related Software Problem 4
Fracture 3
Break 3
No Device Output 2
Device Damaged Prior to Use 2
Device Inoperable 2
Device Contamination with Body Fluid 2
Smoking 2
Use of Device Problem 1
Deflation Problem 1
Retraction Problem 1
Contamination / decontamination Problem 1
Adverse Event Without Identified Device or Use Problem 1
Balloon 1
Loss of Data 1
Improper or Incorrect Procedure or Method 1
Human-Device Interface Problem 1
Misassembled During Installation 1
Positioning Problem 1
Output Problem 1
Pressure Problem 1
Plug 1
Patient Data Problem 1
Intermittent loss of power 1
Relay 1
Total Device Problems 836

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Jan-30-2014
2 Remel Inc II Jun-25-2015
3 Remel Inc II Jul-15-2014
4 bioMerieux, Inc. II Oct-24-2018
5 bioMerieux, Inc. II Feb-04-2016

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