• 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 device, microtiter diluting/dispensing
Regulation Description Microtiter diluting and dispensing device.
Product CodeJTC
Regulation Number 866.2500
Device Class 1

MDR Year MDR Reports MDR Events
2019 102 102
2020 2 2
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 96 96
Patient Data Problem 58 58
Electrical Power Problem 57 57
Use of Device Problem 56 56
Installation-Related Problem 44 44
Data Problem 26 26
Incorrect, Inadequate or Imprecise Resultor Readings 15 15
False Negative Result 2 2
Structural Problem 2 2
Difficult to Open or Close 2 2
Break 1 1
Positioning Failure 1 1
Unintended System Motion 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 91 91
Test Result 7 7
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
Injury 2 2
No Code Available 1 1
Exposure to Body Fluids 1 1
Head Injury 1 1
Laceration(s) 1 1
Tissue Damage 1 1
Sprain 1 1
Concussion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Aug-30-2019
-
-