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 reagent red blood cells
Definition For the detection of or identification of human blood-group antibodies
Product CodeQHT
Regulation Number 660.30
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 3 3
2019 14 40
2020 89 172
2021 60 60
2022 48 48
2023 45 45
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 182 290
Adverse Event Without Identified Device or Use Problem 37 37
Incorrect, Inadequate or Imprecise Result or Readings 24 24
False Positive Result 17 18
No Apparent Adverse Event 4 4
Defective Device 3 3
Improper Chemical Reaction 2 2
Defective Component 1 1
Off-Label Use 1 1
Break 1 1
Cross Reactivity 1 1
Erratic Results 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 172 172
No Known Impact Or Consequence To Patient 69 125
Test Result 9 62
Chills 5 5
No Consequences Or Impact To Patient 5 5
Reaction 4 4
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fever 2 2
Nausea 2 2
Therapeutic Effects, Unexpected 1 1
Jaundice 1 1
Hyperbilirubinemia 1 1
Laceration(s) 1 1
Chest Pain 1 1

-
-