Recall Register

Leica Microsystems, Inc.: FDA recalls

FDA enforcement reports name Leica Microsystems, Inc. as the recalling firm in 33 events. The events have 40 product records. The recalls started from 2012 to 2022. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

33 events, newest first.

FDA enforcement events of Leica Microsystems, Inc.
InitiatedProduct (first record)TypeClassRecordsStatus
21 Nov 2022Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope systemDeviceClass II3Ongoing
26 Aug 2022Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063DeviceClass II4Ongoing
3 Nov 2021Leica Microsystems M220 F12 Microscope SystemsDeviceClass II1Terminated
30 Jul 2021BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375DeviceClass II1Terminated
20 May 2020Leica ARveo and M530 OH6 microscope systems.DeviceClass II1Terminated
18 Nov 2019BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary…DeviceClass II1Ongoing
3 May 2019Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.DeviceClass II1Terminated
2 Jan 2019Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.DeviceClass II1Terminated
17 Sep 2018BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instrumentsDeviceClass II1Terminated
4 Sep 2018Leica M525 F20 Surgical Microscope SystemDeviceClass II1Terminated
4 Sep 2018Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.DeviceClass II1Terminated
25 Jun 2018Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.DeviceClass II1Terminated
13 Jun 2018Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.DeviceClass II1Terminated
4 Jun 2018Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for…DeviceClass II1Terminated
25 Sep 2017PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.DeviceClass II1Terminated
19 Jun 2017Nussloch GmbH ASP6025 Tissue ProcessorDeviceClass II1Ongoing
5 Apr 2016Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.DeviceClass II2Terminated
22 Mar 2016Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.DeviceClass II1Terminated
11 Jan 2016Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.DeviceClass II1Terminated
30 Dec 2015This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond„ system.DeviceClass II1Terminated
27 Nov 2015Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The ‘Intended Use‘ states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse…DeviceClass II1Terminated
3 Sep 2015Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.DeviceClass II1Terminated
5 Aug 2015The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.DeviceClass III1Terminated
27 Jul 2015The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.DeviceClass II1Terminated
16 Dec 2014Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be…DeviceClass II1Terminated
18 Apr 2014Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody…DeviceClass II1Terminated
26 Feb 2014Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.DeviceClass II1Terminated
10 Jan 2014Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.DeviceClass II1Terminated
11 Sep 2013Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.DeviceClass II2Terminated
4 Apr 2013LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.DeviceClass II1Terminated
14 Nov 2012Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica…DeviceClass II1Terminated
13 Nov 2012Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.DeviceClass II1Terminated
4 Jun 2012Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Leica Microsystems, Inc.: events for each product type
TypeEvents
Device33
Leica Microsystems, Inc.: events in each class
ClassEvents
Class II32
Class III1
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
4

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Leica Microsystems, Inc., by the year that the recall started. The largest year is 2018, with 6 events.

Official channels

Cite this page

Recall Register. Leica Microsystems, Inc.: FDA recalls. https://recallregister.com/firm/leica-microsystems-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
IL

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Leica Microsystems, Inc. have?
Class II: 32 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Leica Microsystems, Inc.?
FDA event 91200, which the firm started on 21 Nov 2022. The first product in the record is: Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
How many FDA recalls of Leica Microsystems, Inc. have the status Ongoing?
4 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.