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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 3958
Test Strip 1809
Incorrect Or Inadequate Test Results 982
Low Test Results 600
Non Reproducible Results 597
Incorrect, Inadequate or Imprecise Result or Readings 322
Image Display Error / Artifact 174
Display 54
Adverse Event Without Identified Device or Use Problem 53
Incorrect Measurement 52
Display or Visual Feedback Problem 43
Improper or Incorrect Procedure or Method 37
No Display / Image 26
Device Issue 12
Unauthorized Access to Computer System 10
Insufficient Information 9
High Readings 8
Device Displays Incorrect Message 7
Thermal Decomposition of Device 7
PC (Printed Circuit) Board 6
Display Difficult to Read 6
Erratic or Intermittent Display 6
Melted 6
Use of Device Problem 6
False Positive Result 5
Circuit Failure 4
Unexpected Therapeutic Results 4
No Apparent Adverse Event 4
Appropriate Term/Code Not Available 4
Patient Data Problem 4
Unable to Obtain Readings 3
Date/Time-Related Software Problem 3
Housing 3
Circuit Board 3
Electrical /Electronic Property Problem 3
Mechanical Problem 3
Nonstandard device 2
Power Supply 2
Label 2
Low Readings 2
Expiration Date Error 2
Failure to Read Input Signal 2
Smoking 2
Device Handling Problem 2
Human-Device Interface Problem 2
Device Markings / Labelling Problem 2
Device Contamination with Chemical or Other Material 1
Human Factors Issue 1
Loss of Data 1
Device Subassembly 1
Inaccurate Information 1
Missing Test Results 1
Inadequate Service 1
Pin 1
Screen 1
Computer Software Problem 1
Use of Incorrect Control Settings 1
Corroded 1
Valve 1
Chassis 1
Cover 1
LED (Light Emitting Diode) 1
Battery 1
Occlusion Within Device 1
No Device Output 1
Labelling, Instructions for Use or Training Problem 1
Device Expiration Issue 1
False Negative Result 1
False Reading From Device Non-Compliance 1
Total Device Problems 8876

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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