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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
Regulation Description 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
2020 2 2
2021 1 1
2022 4 4
2023 1 1
2024 3 3
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 7 7
False Negative Result 4 4
Adverse Event Without Identified Device or Use Problem 4 4
False Positive Result 2 2
Unstable 1 1
Off-Label Use 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Insufficient Information 8 8
Death 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agilent Technologies Denmark ApS II Sep-15-2025
2 Biocare Medical, LLC II Jun-05-2020
3 Cell Marque Corporation III Aug-18-2021
4 Leica Microsystems, Inc. II Sep-16-2021
5 Ventana Medical Systems, Inc. II Aug-16-2024
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