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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device test, hepatitis b (b core, be antigen, be antibody, b core igm)
Product CodeLOM
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023 2024
73 36 53 60 70 63 29

MDR Year MDR Reports MDR Events
2018 112 112
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 347 347
False Negative Result 261 261
High Test Results 188 188
No Apparent Adverse Event 112 112
Low Test Results 59 59
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Non Reproducible Results 21 21
Adverse Event Without Identified Device or Use Problem 13 13
Incorrect Or Inadequate Test Results 10 10
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 361 361
No Consequences Or Impact To Patient 76 76
Insufficient Information 6 6
Hepatitis 5 5
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
5 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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