• 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 calibrator, secondary
Product CodeJIT
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 7 7
2018 8 8
2019 215 215
2020 12 12
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 221 221
Low Test Results 14 14
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Adverse Event Without Identified Device or Use Problem 5 5
Calibration Problem 4 4
Device Ingredient or Reagent Problem 1 1
Non Reproducible Results 1 1
Failure to Calibrate 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 200 200
No Known Impact Or Consequence To Patient 29 29
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 5 5
No Code Available 2 2
Exposure to Body Fluids 2 2
Eye Injury 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories II Apr-09-2020
3 Abbott Laboratories III Jul-25-2019
4 Abbott Laboratories III May-16-2019
5 Medica Corporation II Mar-28-2018
6 Ortho-Clinical Diagnostics III Feb-09-2017
7 Randox Laboratories Ltd. II Mar-15-2019
8 Siemens Healthcare Diagnostics, Inc II Apr-19-2017
9 Siemens Healthcare Diagnostics, Inc. II Oct-13-2020
10 Siemens Healthcare Diagnostics, Inc. II Jan-29-2019
11 Siemens Healthcare Diagnostics, Inc. III Feb-16-2017
12 Tosoh Bioscience Inc II Sep-14-2020
13 Tosoh Bioscience Inc II May-14-2018
-
-