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 system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
Definition A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
Product CodePEX
Regulation Number 866.3361
Device Class 2

MDR Year MDR Reports MDR Events
2019 107 107
2020 89 89
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 197 197
Sparking 1 1
Output Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 106 106
No Patient Involvement 61 61
No Consequences Or Impact To Patient 28 28
No Clinical Signs, Symptoms or Conditions 4 4
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
-
-