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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

Device Problems
Material fragmentation 2
False negative result 2
False positive result 1
Device operates differently than expected 1
Manufacturing or shipping issue associated with device 1
No Known Device Problem 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 2 1 5 0 5 5 5
Class III 0 0 0 0 2 0 0 0 1 2

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 III Apr-19-2016
5 Biocare Medical, LLC II Nov-09-2015
6 Biocare Medical, LLC III May-26-2015
7 Biocare Medical, LLC II Apr-27-2015
8 Cell Marque Corporation II Jun-17-2016
9 Cell Marque Corporation II Mar-06-2012
10 Cell Marque Corporation III Aug-31-2011
11 Lab Vision Corporation III Feb-17-2016
12 Lab Vision Corporation II Feb-22-2012
13 Lab Vision Corporation II Sep-15-2010
14 Leica Biosystems Newcastle Ltd. II Jan-10-2014
15 Leica Microsystems, Inc. II Jun-01-2016
16 Leica Microsystems, Inc. II May-21-2016
17 Leica Microsystems, Inc. II Feb-19-2016
18 Leica Microsystems, Inc. II Feb-12-2016
19 Leica Microsystems, Inc. II Nov-25-2015
20 Leica Microsystems, Inc. II Mar-24-2015
21 Leica Microsystems, Inc. II Nov-06-2014
22 Leica Microsystems, Inc. II Jun-04-2014
23 Leica Microsystems, Inc. II Jun-02-2014
24 Leica Microsystems, Inc. II Dec-13-2012
25 Leica Microsystems, Inc. II Feb-17-2012
26 Leica Microsystems, Inc. III Sep-09-2011
27 Leica Microsystems, Inc. II Feb-09-2011
28 Leica Microsystems, Inc. II Sep-25-2010

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