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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
DIASORIN INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 26 26
2018 61 61
2019 51 51
2020 104 104
2021 12 12
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 135 135
False Positive Result 85 85
False Negative Result 12 12
Incorrect Or Inadequate Test Results 12 12
Low Test Results 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Patient Data Problem 1 1
Non Reproducible Results 1 1
High Readings 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 164 164
No Patient Involvement 54 54
No Consequences Or Impact To Patient 23 23
No Clinical Signs, Symptoms or Conditions 16 16
Hepatitis 2 2

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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