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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product CodeLOM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
36 53 60 70 63 29

MDR Year MDR Reports MDR Events
2019 191 191
2020 139 139
2021 147 147
2022 139 139
2023 163 163
2024 99 99

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 334 334
False Negative Result 246 246
High Test Results 161 161
No Apparent Adverse Event 94 94
Low Test Results 42 42
Incorrect, Inadequate or Imprecise Result or Readings 31 31
Non Reproducible Results 20 20
Leak/Splash 3 3
Improper or Incorrect Procedure or Method 2 2
Appropriate Term/Code Not Available 2 2
Insufficient Information 1 1
Incorrect Measurement 1 1
High Readings 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 550 550
No Known Impact Or Consequence To Patient 271 271
No Consequences Or Impact To Patient 55 55
Insufficient Information 6 6
Hepatitis 4 4
Vomiting 1 1
Missing Value Reason 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
2 Ortho-Clinical Diagnostics, Inc. II Jun-13-2024
3 Ortho-Clinical Diagnostics, Inc. II Jan-19-2024
4 Siemens Healthcare Diagnostics, Inc. II Feb-17-2023
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