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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device hepatitis a test (antibody and igm antibody)
Product CodeLOL
Regulation Number 866.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BIO-RAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 4
DIASORIN, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
ROCHE PROFESSIONAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 19 19
2015 28 28
2016 36 36
2017 26 26
2018 61 61
2019 51 51
2020 104 104
2021 12 12
2022 17 17
2023 36 36
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 178 178
High Test Results 154 154
False Negative Result 20 20
Incorrect Or Inadequate Test Results 20 20
Adverse Event Without Identified Device or Use Problem 15 15
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Non Reproducible Results 6 6
Low Test Results 6 6
False Reading From Device Non-Compliance 2 2
Output Problem 1 1
Insufficient Information 1 1
Patient Data Problem 1 1
High Readings 1 1
Optical Problem 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 215 215
No Clinical Signs, Symptoms or Conditions 80 80
No Patient Involvement 54 54
No Consequences Or Impact To Patient 54 54
Hepatitis 2 2
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics International, Ltd. II May-19-2010
2 Abbott Gmbh & Co. KG II Apr-17-2020
3 Abbott Gmbh & Co. KG II Nov-26-2019
4 Abbott Laboratories II Jun-06-2011
5 Roche Diagnostics Corporation II Jan-29-2019
6 Roche Diagnostics Operations, Inc. II Dec-12-2019
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