Leica Microsystems, Inc.
Medical device manufacturer in deerfield, IL.
2510(k) clearances
0PMA approvals
59recalls
Device types
510(k) clearances
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0477-2023 Class II | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope systemThere is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | 11/21/2022Open, Classified |
| Z-0476-2023 Class II | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard).…There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | 11/21/2022Open, Classified |
| Z-0475-2023 Class II | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemThere is a potential issue resulting in the Power Supply potentially becoming overheated due to internal… | 11/21/2022Open, Classified |
| Z-1851-2022 Class II | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside… | 08/26/2022Open, Classified |
| Z-1850-2022 Class II | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside… | 08/26/2022Open, Classified |
| Z-1849-2022 Class II | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside… | 08/26/2022Open, Classified |
| Z-1848-2022 Class II | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside… | 08/26/2022Open, Classified |
| Z-0412-2022 Class II | Leica Microsystems M220 F12 Microscope SystemsIn May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope… | 11/03/2021Terminated |
| Z-2481-2021 Class II | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375Product may not perform as specified in IFU. | 07/30/2021Terminated |
| Z-2399-2020 Class II | Leica ARveo and M530 OH6 microscope systems.Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in… | 05/20/2020Terminated |
| Z-0673-2020 Class II | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in…BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified… | 11/18/2019Open, Classified |
| Z-1729-2019 Class II | Leica Cryostats, used to produce frozen sample sections for biological, medical and…The current labelling does not include any specific warning about usage of flammable freezing sprays. Such… | 05/03/2019Terminated |
| Z-0772-2019 Class II | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical…The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. | 01/02/2019Terminated |
| Z-0281-2019 Class II | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III…The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard… | 09/17/2018Terminated |
| Z-3175-2018 Class II | Leica M525 F20 Surgical Microscope SystemThe firm received complaints that the instrument tipped over when the swing arm was fully extended. | 09/04/2018Terminated |
| Z-0019-2019 Class II | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and…Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results… | 09/04/2018Terminated |
| Z-2659-2018 Class II | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.Recall is due to a design weakness of the power insert module. | 06/25/2018Terminated |
| Z-0064-2019 Class II | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The…These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault… | 06/13/2018Terminated |
| Z-2555-2018 Class II | Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with…Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas… | 06/04/2018Terminated |
| Z-0838-2019 Class II | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of…The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement… | 09/25/2017Terminated |
| Z-2660-2017 Class II | Nussloch GmbH ASP6025 Tissue ProcessorIncorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | 06/19/2017Open, Classified |
| Z-1877-2016 Class II | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment…Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date… | 04/05/2016Terminated |
| Z-1876-2016 Class II | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is…Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the… | 04/05/2016Terminated |
| Z-1704-2016 Class II | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for…Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of… | 03/22/2016Terminated |
| Z-1499-2016 Class II | Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope.…An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination… | 01/11/2016Terminated |
| Z-0823-2016 Class II | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended…The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining… | 12/30/2015Terminated |
| Z-0808-2016 Class II | Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is…The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the… | 11/27/2015Terminated |
| Z-0341-2016 Class II | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in…These Lot numbers are not stable up to the expiry date on the product labeling. | 09/03/2015Terminated |
| Z-2779-2015 Class III | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The…The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which… | 08/05/2015Terminated |
| Z-2804-2015 Class II | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica…The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort… | 07/27/2015Terminated |
| Z-1315-2015 Class II | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform…The staining intensity decreases over the shelf life. | 12/16/2014Terminated |
| Z-0179-2015 Class II | Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue…Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the… | 04/18/2014Terminated |
| Z-1698-2014 Class II | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi…Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438)… | 02/26/2014Terminated |
| Z-1710-2014 Class II | Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant…Product does not function as intended up to the expiry date on the product labeling. There is a link between… | 01/10/2014Terminated |
| Z-1726-2014 Class II | Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article…The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and… | 09/11/2013Terminated |
| Z-1725-2014 Class II | Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article…The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and… | 09/11/2013Terminated |
| Z-1446-2013 Class II | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846…An LPC Fine Mesh Cassette failed to stay closed during processing operations. | 04/04/2013Terminated |
| Z-0521-2013 Class II | Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase…RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. | 11/14/2012Terminated |
| Z-1815-2013 Class II | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor…The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To… | 11/13/2012Terminated |
| Z-2053-2012 Class II | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz)…Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be… | 06/04/2012Terminated |
| Z-1473-2012 | ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica…There is a potential malfunction with the device in autorotation mode, which can lead to incorrect reagent… | 03/30/2012Terminated |
| Z-1269-2012 | Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO…The screws, which lock the bottom plate to the spindle, pull through allowing the carrier arm with touch… | 02/27/2012Terminated |
| Z-1054-2012 | Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro…The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. | 01/10/2012Terminated |
| Z-1053-2012 | Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro…The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. | 01/10/2012Terminated |
| Z-1052-2012 | Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic…The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. | 01/10/2012Terminated |
| Z-1042-2012 | Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F…Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope… | 12/21/2011Terminated |
| Z-3182-2011 | Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in…There was an issue with the controlled temperature storage unit where the products were stored prior to… | 07/26/2011Terminated |
| Z-3181-2011 | Leica Bond Ready-to-Use Primary Antibody CDX2 (AMT28); an in vitro diagnostic…There was an issue with the controlled temperature storage unit where the products were stored prior to… | 07/26/2011Terminated |
| Z-3180-2011 | Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry…There was an issue with the controlled temperature storage unit where the products were stored prior to… | 07/26/2011Terminated |
| Z-2597-2011 | Peloris II Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly…The processor potentially has a faulty impellor which could lead to reagent carry-over from one processing… | 04/11/2011Terminated |
| Z-1065-2011 | Bond Polymer Refine Detection Kit; an in vitro diagnostic immunohistochemistry reagent…Users of the Bond Polymer Refine Detection System, DS9800, may experience instances of "weak staining" due… | 11/16/2010Terminated |
| Z-2499-2010 | Liquid Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 1 mL liquid tissue…In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor… | 08/02/2010Terminated |
| Z-2498-2010 | Lyophilized Mouse Monoclonal Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL…In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor… | 08/02/2010Terminated |
| Z-2497-2010 | Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1 (SPT24); 7 mL vial; an…In combination with a sensitive polymer detection system, the TTF-1 antibodies may stain additional tumor… | 08/02/2010Terminated |
| Z-1633-2010 | Leica Wireless Footswitch, Type B used in conjunction with Leica Surgical Microscopes -…The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position. | 03/29/2010Terminated |
| Z-1632-2010 | Leica Footswitch, Type B used in conjunction with Leica Surgical Microscopes - Models…The pedals of the Footswitch Type B stick and the Zoom/Focus moves to the end position. | 03/29/2010Terminated |
| Z-1551-2010 | Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149…Confusion during manually changing reagents, general users running unvalidated protocols, and wax valve… | 02/09/2010Terminated |
| Z-1221-2010 | Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS…A manufacturing defect was identified that could potentially result in the laser shutter not closing as… | 11/12/2009Terminated |
| Z-1040-2009 | QCA and iQCA software, a video microscopy software system for quantitative estrogen…A change in the software to open up the software architecture to include other analytes other than Estrogen… | 11/06/2008Terminated |