• 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 enzyme immunoassay, diphenylhydantoin
Regulation Description Diphenylhydantoin test system.
Product CodeDIP
Regulation Number 862.3350
Device Class 2

MDR Year MDR Reports MDR Events
2017 55 55
2018 79 79
2019 25 25
2020 17 17
2021 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 117 117
Low Test Results 63 63
No Apparent Adverse Event 42 42
Incorrect, Inadequate or Imprecise Resultor Readings 26 26
Incorrect Or Inadequate Test Results 10 10
High Readings 7 7
Low Readings 4 4
Device Operates Differently Than Expected 2 2
Use of Incorrect Control Settings 2 2
False Reading From Device Non-Compliance 1 1
Use of Device Problem 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 144 144
No Clinical Signs, Symptoms or Conditions 54 54
No Consequences Or Impact To Patient 25 25
Test Result 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Jul-03-2018
2 Ortho-Clinical Diagnostics II Dec-22-2017
3 Ortho-Clinical Diagnostics, Inc. II Feb-19-2021
-
-