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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 test, time, prothrombin
Regulation Description Prothrombin time test.
Product CodeGJS
Regulation Number 864.7750
Device Class 2


Premarket Reviews
ManufacturerDecision
ILINE MICROSYSTEMS S.L.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS OPERATIONS, INC
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 3610
Test Strip 1807
Incorrect Or Inadequate Test Results 982
Low Test Results 541
Non Reproducible Results 506
Incorrect, Inadequate or Imprecise Result or Readings 311
Image Display Error / Artifact 160
Display 53
Adverse Event Without Identified Device or Use Problem 53
Display or Visual Feedback Problem 40
Improper or Incorrect Procedure or Method 37
No Display / Image 26
Device Issue 12
Unauthorized Access to Computer System 10
Insufficient Information 9
Device Displays Incorrect Message 7
Thermal Decomposition of Device 6
Erratic or Intermittent Display 6
Use of Device Problem 6
PC (Printed Circuit) Board 6
Melted 5
False Positive Result 5
Unexpected Therapeutic Results 4
Appropriate Term/Code Not Available 4
Patient Data Problem 4
No Apparent Adverse Event 4
Electrical /Electronic Property Problem 3
Unable to Obtain Readings 3
Circuit Board 3
Housing 3
Mechanical Problem 3
Smoking 2
Failure to Read Input Signal 2
Power Supply 2
Low Readings 2
Device Markings / Labelling Problem 2
Human-Device Interface Problem 2
Expiration Date Error 2
Label 2
Nonstandard device 2
Date/Time-Related Software Problem 2
Loss of Data 1
Valve 1
False Negative Result 1
Pin 1
Corroded 1
False Reading From Device Non-Compliance 1
Device Subassembly 1
Chassis 1
Labelling, Instructions for Use or Training Problem 1
Display Difficult to Read 1
Inaccurate Information 1
LED (Light Emitting Diode) 1
Battery 1
Device Handling Problem 1
High Readings 1
Cover 1
Occlusion Within Device 1
Inadequate Service 1
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Missing Test Results 1
Screen 1
Use of Incorrect Control Settings 1
Device Expiration Issue 1
Total Device Problems 8273

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Point Of Care Inc. II Aug-10-2015
2 Alere San Diego, Inc. I Aug-19-2016
3 Alere San Diego, Inc. I Jan-03-2015
4 Diagnostica Stago, Inc. II Sep-07-2018
5 Diagnostica Stago, Inc. II Mar-15-2018
6 Fisher Diagnostics, A Company of Fisher Scientific LLC II Jun-26-2015
7 Instrumentation Laboratory Co. II Oct-05-2018
8 Instrumentation Laboratory Co. II Mar-03-2018
9 Roche Diagnostics Corporation I Nov-02-2018
10 TERRIFIC CARE LLC I Feb-01-2019

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