• 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, anaerobic identification
Product CodeJSP
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2017 23 23
2018 10 10
2020 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 30 30
Incorrect, Inadequate or Imprecise Resultor Readings 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 21 21
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 2 2
Patient Problem/Medical Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Jun-12-2018
2 Biomerieux Inc II May-22-2017
-
-