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 (two-site solid phase), ferritin
Product CodeJMG
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 4 4
2021 5 5
2022 2 2
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 14 14
High Test Results 12 12
Non Reproducible Results 12 12
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1
High Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 6 6
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Aug-08-2019
-
-