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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
2015 4 4
2016 1 1
2017 1 1
2018 10 10
2019 1 1
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 5 5
False Negative Result 4 4
False Positive Result 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Incorrect Or Inadequate Test Results 2 2
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 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
No Known Impact Or Consequence To Patient 4 4
Cancer 3 3
Misdiagnosis 3 3
Hypersensitivity/Allergic reaction 2 2
Therapeutic Effects, Unexpected 1 1
No Consequences Or Impact To Patient 1 1
Anxiety 1 1
Arthralgia 1 1
Reaction, Injection Site 1 1
No Patient Involvement 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocare Medical Llc II Jan-13-2015
2 Biocare Medical, LLC II Jun-05-2020
3 Biocare Medical, LLC II Sep-19-2018
4 Biocare Medical, LLC II Jul-05-2018
5 Biocare Medical, LLC III Apr-19-2016
6 Biocare Medical, LLC II Nov-09-2015
7 Biocare Medical, LLC III May-26-2015
8 Biocare Medical, LLC II Apr-27-2015
9 Cell Marque Corporation II Jun-17-2016
10 Lab Vision Corporation III Feb-17-2016
11 Leica Biosystems Richmond Inc. II Sep-12-2017
12 Leica Microsystems, Inc. II Dec-12-2019
13 Leica Microsystems, Inc. II Jun-01-2016
14 Leica Microsystems, Inc. II May-21-2016
15 Leica Microsystems, Inc. II Feb-19-2016
16 Leica Microsystems, Inc. II Feb-12-2016
17 Leica Microsystems, Inc. II Nov-25-2015
18 Leica Microsystems, Inc. II Mar-24-2015
19 Ventana Medical Systems Inc I Sep-14-2018
20 Ventana Medical Systems Inc I Feb-27-2018
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