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 blood grouping reagent
Definition For red blood cell antigen typing
Product CodeQHR
Regulation Number 660.20
Device Class Unclassified

MDR Year MDR Reports MDR Events
2019 17 17
2020 84 84
2021 90 90
2022 64 64
2023 82 82
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 196 196
False Negative Result 72 72
Adverse Event Without Identified Device or Use Problem 52 52
Incorrect, Inadequate or Imprecise Result or Readings 35 35
Improper or Incorrect Procedure or Method 14 14
Output Problem 13 13
No Apparent Adverse Event 10 10
Defective Device 8 8
Defective Component 4 4
Patient Device Interaction Problem 2 2
Off-Label Use 2 2
Incorrect Measurement 2 2
Short Fill 1 1
Component Missing 1 1
Appropriate Term/Code Not Available 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 344 344
No Known Impact Or Consequence To Patient 47 47
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
Reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Test Result 2 2
Hemolysis 1 1
Laceration(s) 1 1

-
-