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 biuret (colorimetric), total protein
Product CodeCEK
Regulation Number 862.1635
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2
2021 1 1
2023 14 14
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 18 18
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Output Problem 3 3
High Test Results 3 3
Chemical Problem 1 1
No Apparent Adverse Event 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Jan-12-2021
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
3 Siemens Healthcare Diagnostics, Inc. II Oct-28-2021
-
-