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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunohistochemistry reagents and kits
Definition according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Product CodeNJT
Regulation Number 864.1860
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 10 10
2019 1 1
2020 2 2
2021 1 1
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 4 4
False Negative Result 2 2
Incorrect Or Inadequate Test Results 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
False Positive Result 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 7 7
Pain 6 6
Rash 6 6
Reaction 5 5
Insufficient Information 4 4
Cancer 3 3
Hypersensitivity/Allergic reaction 2 2
Reaction, Injection Site 1 1
No Patient Involvement 1 1
Therapeutic Effects, Unexpected 1 1
No Consequences Or Impact To Patient 1 1
Arthralgia 1 1
Death 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocare Medical, LLC II Jun-05-2020
2 Biocare Medical, LLC II Sep-19-2018
3 Biocare Medical, LLC II Jul-05-2018
4 Cell Marque Corporation III Aug-18-2021
5 Leica Biosystems Richmond Inc. II Sep-12-2017
6 Leica Microsystems, Inc. II Sep-16-2021
7 Leica Microsystems, Inc. II Dec-12-2019
8 Ventana Medical Systems Inc I Sep-14-2018
9 Ventana Medical Systems Inc I Feb-27-2018
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