• 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 radioimmunoassay, estradiol
Regulation Description Estradiol test system.
Product CodeCHP
Regulation Number 862.1260
Device Class 1

MDR Year MDR Reports MDR Events
2016 29 29
2017 39 39
2018 38 38
2019 36 39
2020 135 135
2021 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 123 126
Low Test Results 67 67
Incorrect, Inadequate or Imprecise Resultor Readings 64 64
Adverse Event Without Identified Device or Use Problem 26 26
Non Reproducible Results 17 17
No Apparent Adverse Event 14 14
Incorrect Or Inadequate Test Results 14 14
Calibration Problem 6 6
Incorrect Measurement 5 5
Appropriate Term/Code Not Available 1 1
Insufficient Information 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 180 183
No Consequences Or Impact To Patient 48 48
No Code Available 41 41
No Clinical Signs, Symptoms or Conditions 33 33
Misdiagnosis 6 6
Overdose 4 4
Insufficient Information 3 3
Therapeutic Response, Increased 2 2
No Patient Involvement 2 2
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II May-16-2019
2 Abbott Ireland Diagnostics Division II Dec-22-2018
3 Abbott Laboratories II May-31-2016
4 BioMerieux SA II Mar-20-2017
5 Diasorin Inc. II Nov-21-2016
6 ORTHO-CLINICAL DIAGNOSTICS II Aug-05-2016
7 Roche Diagnostics Operations, Inc. II Mar-31-2016
8 Siemens Healthcare Diagnostics, Inc II Feb-04-2018
9 Siemens Healthcare Diagnostics, Inc II Mar-24-2016
10 Siemens Healthcare Diagnostics, Inc. II Feb-24-2020
11 Siemens Healthcare Diagnostics, Inc. II Jul-13-2018
12 Siemens Healthcare Diagnostics, Inc. II May-05-2017
13 Tosoh Bioscience Inc II Jun-05-2018
-
-