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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)
Regulation Description Hepatitis A virus (HAV) serological assays.
Product CodeLOL
Regulation Number 866.3310
Device Class 2


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

MDR Year MDR Reports MDR Events
2020 104 104
2021 12 12
2022 17 17
2023 36 36
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 92 92
High Test Results 80 80
False Negative Result 16 16
Non Reproducible Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Output Problem 2 2
Optical Problem 1 1
Incorrect Measurement 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Patient Involvement 53 53
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Gmbh & Co. KG II Apr-17-2020
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