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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
BECKMAN COULTER INC.
  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
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 104 104
High Test Results 80 80
False Negative Result 18 18
Non Reproducible Results 5 5
Output Problem 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Measurement 2 2
Insufficient Information 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 98 98
No Patient Involvement 53 53
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 5 5
Liver Failure 1 1
Insufficient Information 1 1

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