Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
2020 135 135
2021 43 43
2022 61 61
2023 60 60
2024 67 67
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 223 223
Low Test Results 91 91
Non Reproducible Results 62 62
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Incorrect Measurement 20 20
Low Readings 4 4
High Readings 3 3
Mechanical Problem 2 2
Insufficient Information 2 2
Material Integrity Problem 2 2
Calibration Problem 2 2
Failure to Calibrate 2 2
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
No Known Impact Or Consequence To Patient 86 86
Insufficient Information 35 35
No Code Available 32 32
No Consequences Or Impact To Patient 17 17
Overdose 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Therapeutic Response, Increased 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Siemens Healthcare Diagnostics, Inc. II Apr-29-2022
3 Siemens Healthcare Diagnostics, Inc. II Feb-24-2020
4 bioMerieux, Inc. II Dec-28-2021
-
-