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 susceptibility test powders, antimycobacterial
Product CodeMJA
Regulation Number 866.1640
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 10 10
2023 43 43
2024 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 84 84
Contamination 5 5
False Positive Result 4 4
Contamination of Device Ingredient or Reagent 2 2
Device Markings/Labelling Problem 2 2
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
Bacterial Infection 3 3
Insufficient Information 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II May-05-2011
-
-