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


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 116 116
High Test Results 97 97
False Negative Result 15 15
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Non Reproducible Results 5 5
Output Problem 1 1
Insufficient Information 1 1
Optical Problem 1 1
Patient Data Problem 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 91 91
No Clinical Signs, Symptoms or Conditions 80 80
No Patient Involvement 54 54
No Consequences Or Impact To Patient 11 11

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II Apr-17-2020
2 Abbott Gmbh & Co. KG II Nov-26-2019
3 Roche Diagnostics Corporation II Jan-29-2019
4 Roche Diagnostics Operations, Inc. II Dec-12-2019
-
-