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 kit, identification, yeast
Product CodeJXB
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2017 18 18
2018 27 27
2019 19 19
2020 12 12
2021 37 37
2022 10 10
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 98 98
Incorrect Or Inadequate Test Results 30 30
Nonstandard Device 6 6
False Negative Result 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 33 33
No Patient Involvement 28 28
No Consequences Or Impact To Patient 17 18
Misdiagnosis 1 1
Death 1 1
Fungal Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II Jan-25-2022
3 Biomerieux Inc II May-22-2017
-
-