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 molecular erythrocyte typing test
Definition Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
Product CodePEP
Device Class 3

MDR Year MDR Reports MDR Events
2016 33 33
2017 29 29
2018 18 18
2019 26 26
2020 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 59 59
False Positive Result 28 28
Incorrect Or Inadequate Test Results 27 27
False Negative Result 17 17
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 75 75
No Consequences Or Impact To Patient 36 36
No Information 12 12
No Clinical Signs, Symptoms or Conditions 9 9
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Test Result 2 2
Insufficient Information 1 1

-
-