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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device system, test, automated blood grouping and antibody
Regulation Description Automated blood grouping and antibody test system.
Product CodeKSZ
Regulation Number 864.9175
Device Class 2

Device Problems
False negative result 36
Failure to deliver 12
Incorrect or inadequate test results 9
Fluid leak 9
Device operates differently than expected 9
False positive result 7
Infusion or flow issue 6
Communication or transmission issue 4
Bent 3
Improper or incorrect procedure or method 3
Program, failure to 1
Contamination of device ingredient or reagent 1
Excess flow or overinfusion 1
Temperature issue 1
Incorrect display 1
Inaccurate dispensing 1
Incorrect or inadequate result 1
Device displays error message 1
Data back-up problem 1
Total Device Problems 107

-
-