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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
2019 1 1
2020 2 2
2021 1 1
2022 4 4
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Adverse Event Without Identified Device or Use Problem 4 4
False Negative Result 1 1
False Positive Result 1 1
Off-Label Use 1 1
Unstable 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Death 1 1
Therapeutic Effects, Unexpected 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocare Medical, LLC II Jun-05-2020
2 Cell Marque Corporation III Aug-18-2021
3 Leica Microsystems, Inc. II Sep-16-2021
4 Leica Microsystems, Inc. II Dec-12-2019
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