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Leica Microsystems, Inc.

45 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system recall (Z-0475-2023)Leica Microsystems, Inc.2022-12-09
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical recall (Z-0476-2023)Leica Microsystems, Inc.2022-12-09
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system recall (Z-0477-2023)Leica Microsystems, Inc.2022-12-09
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 recall (Z-1848-2022)Leica Microsystems, Inc.2022-09-29
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 recall (Z-1849-2022)Leica Microsystems, Inc.2022-09-29
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 recall (Z-1850-2022)Leica Microsystems, Inc.2022-09-29
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950 recall (Z-1851-2022)Leica Microsystems, Inc.2022-09-29
Leica Cryostats, used to produce frozen sample sections for biological, medical and indust recall (Z-1729-2019)Leica Microsystems, Inc.2019-06-04
Leica M525 F20 Surgical Microscope System recall (Z-3175-2018)Leica Microsystems, Inc.2018-09-14
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It recall (Z-1499-2016)Leica Microsystems, Inc.2016-04-15
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended t recall (Z-0823-2016)Leica Microsystems, Inc.2016-02-19
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection recall (Z-0808-2016)Leica Microsystems, Inc.2016-02-12
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vit recall (Z-0341-2016)Leica Microsystems, Inc.2015-11-25
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP602 recall (Z-2804-2015)Leica Microsystems, Inc.2015-09-22
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leic recall (Z-2779-2015)Leica Microsystems, Inc.2015-09-17
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical recall (Z-1315-2015)Leica Microsystems, Inc.2015-03-24
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture recall (Z-0179-2015)Leica Microsystems, Inc.2014-11-06
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number recall (Z-1725-2014)Leica Microsystems, Inc.2014-06-07
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Nu recall (Z-1726-2014)Leica Microsystems, Inc.2014-06-07
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant co recall (Z-1710-2014)Leica Microsystems, Inc.2014-06-04
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438) recall (Z-1698-2014)Leica Microsystems, Inc.2014-06-02
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for recall (Z-1815-2013)Leica Microsystems, Inc.2013-07-29
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060 recall (Z-1446-2013)Leica Microsystems, Inc.2013-06-03
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Sta recall (Z-0521-2013)Leica Microsystems, Inc.2012-12-13
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, recall (Z-2053-2012)Leica Microsystems, Inc.2012-07-20
ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems recall (Z-1473-2012)Leica Microsystems, Inc.2012-04-27
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a recall (Z-1269-2012)Leica Microsystems, Inc.2012-03-21
Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic pr recall (Z-1052-2012)Leica Microsystems, Inc.2012-02-17
Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagno recall (Z-1053-2012)Leica Microsystems, Inc.2012-02-17
Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro d recall (Z-1054-2012)Leica Microsystems, Inc.2012-02-17
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affect recall (Z-1042-2012)Leica Microsystems, Inc.2012-02-16
Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry p recall (Z-3180-2011)Leica Microsystems, Inc.2011-09-09
Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic immunohistoc recall (Z-3181-2011)Leica Microsystems, Inc.2011-09-09
Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro recall (Z-3182-2011)Leica Microsystems, Inc.2011-09-09
Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 recall (Z-2597-2011)Leica Microsystems, Inc.2011-06-20
Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent kit recall (Z-1065-2011)Leica Microsystems, Inc.2011-02-09
Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an i recall (Z-2497-2010)Leica Microsystems, Inc.2010-09-25
Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyop recall (Z-2498-2010)Leica Microsystems, Inc.2010-09-25
Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue cultur recall (Z-2499-2010)Leica Microsystems, Inc.2010-09-25
Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models M620 recall (Z-1632-2010)Leica Microsystems, Inc.2010-05-20
Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Mo recall (Z-1633-2010)Leica Microsystems, Inc.2010-05-20
Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VI recall (Z-1551-2010)Leica Microsystems, Inc.2010-05-07
Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 recall (Z-1221-2010)Leica Microsystems, Inc.2010-05-06
QCA and iQCA software, a video microscopy software system for quantitative estrogen recept recall (Z-1040-2009)Leica Microsystems, Inc.2009-03-24
Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnificat recall (Z-1162-06)Leica Microsystems, Inc.2006-06-24

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Every clearance here is in the API, with alerts when new ones post.