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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
2015 4 4
2016 1 1
2017 1 1
2018 11 11
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 5 5
Improper or Incorrect Procedure or Method 5 5
Adverse Event Without Identified Device or Use Problem 5 5
False Negative Result 4 4
False Positive Result 2 2
Off-Label Use 2 2
Incorrect Or Inadequate Test Results 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 8 8
Pain 6 6
Rash 6 6
Insufficient Information 6 6
Reaction 5 5
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Cancer 3 3
Hypersensitivity/Allergic reaction 3 3
Misdiagnosis 3 3
No Consequences Or Impact To Patient 1 1
Anxiety 1 1
Arthralgia 1 1
Therapeutic Effects, Unexpected 1 1
Reaction, Injection Site 1 1
No Patient Involvement 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMS Diagnostics, LLC II Mar-21-2014
2 Biocare Medical Llc II Jan-13-2015
3 Biocare Medical Llc II Apr-10-2012
4 Biocare Medical, LLC II Jun-05-2020
5 Biocare Medical, LLC II Sep-19-2018
6 Biocare Medical, LLC II Jul-05-2018
7 Biocare Medical, LLC III Apr-19-2016
8 Biocare Medical, LLC II Nov-09-2015
9 Biocare Medical, LLC III May-26-2015
10 Biocare Medical, LLC II Apr-27-2015
11 Cell Marque Corporation III Aug-18-2021
12 Cell Marque Corporation II Jun-17-2016
13 Cell Marque Corporation II Mar-06-2012
14 Cell Marque Corporation III Aug-31-2011
15 Lab Vision Corporation III Feb-17-2016
16 Lab Vision Corporation II Feb-22-2012
17 Lab Vision Corporation II Sep-15-2010
18 Leica Biosystems Newcastle Ltd. II Jan-10-2014
19 Leica Biosystems Richmond Inc. II Sep-12-2017
20 Leica Microsystems, Inc. II Sep-16-2021
21 Leica Microsystems, Inc. II Dec-12-2019
22 Leica Microsystems, Inc. II Jun-01-2016
23 Leica Microsystems, Inc. II May-21-2016
24 Leica Microsystems, Inc. II Feb-19-2016
25 Leica Microsystems, Inc. II Feb-12-2016
26 Leica Microsystems, Inc. II Nov-25-2015
27 Leica Microsystems, Inc. II Mar-24-2015
28 Leica Microsystems, Inc. II Nov-06-2014
29 Leica Microsystems, Inc. II Jun-04-2014
30 Leica Microsystems, Inc. II Jun-02-2014
31 Leica Microsystems, Inc. II Dec-13-2012
32 Leica Microsystems, Inc. II Feb-17-2012
33 Leica Microsystems, Inc. III Sep-09-2011
34 Leica Microsystems, Inc. II Feb-09-2011
35 Leica Microsystems, Inc. II Sep-25-2010
36 Ventana Medical Systems Inc I Sep-14-2018
37 Ventana Medical Systems Inc I Feb-27-2018
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