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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 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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 107 107
High Test Results 97 97
False Negative Result 14 14
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Non Reproducible Results 5 5
Low Test Results 1 1
Optical Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Patient Data Problem 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 70 70
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
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