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
2021 43 43
2022 61 61
2023 60 62
2024 65 65
2025 85 85
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 214 215
Non Reproducible Results 87 88
Low Test Results 78 79
Incorrect, Inadequate or Imprecise Result or Readings 33 35
Incorrect Measurement 32 32
Low Readings 4 4
Insufficient Information 3 3
High Readings 3 3
Mechanical Problem 2 2
Material Integrity Problem 2 3
Output Problem 2 2
Failure to Calibrate 2 2
Calibration Problem 2 2
Unable to Obtain Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Damaged Prior to Use 1 1
Defective Device 1 1
Chemical Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 275 277
Insufficient Information 36 36
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 bioMerieux, Inc. II Dec-28-2021
-
-