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Leica Microsystems Recalls
40 recalls on record · August 1, 2012 to December 21, 2022 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 1, 2015Medical DevicesFDA
Leica Microsystems, Inc. recalls Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usa
Hazard: The staining intensity decreases over the shelf life.
November 12, 2014Medical DevicesFDA
Leica Microsystems, Inc. recalls Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in
Hazard: Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.
June 18, 2014Medical DevicesFDA
Leica Microsystems, Inc. recalls Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a suppl
Hazard: The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
June 18, 2014Medical DevicesFDA
Leica Microsystems, Inc. recalls Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply v
Hazard: The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
June 11, 2014Medical DevicesFDA
Leica Microsystems, Inc. recalls Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as
Hazard: Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.
June 11, 2014Medical DevicesFDA
Leica Microsystems, Inc. recalls Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supe
Hazard: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.
August 7, 2013Medical DevicesFDA
Leica Microsystems, Inc. recalls Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory ap
Hazard: The Instruction for Use 1v9 Ref F and all previous versions specify incorrect dimensions for the Ready To Use (RTU) bottles from other suppliers than Leica. In case of a pressure failure of the device in combination with a bottle with incorrect dimensions, overflow can cause contamination of reagents. Additionally, the current instructions for use does not highlight the importance to check the filling levels of all reagent bottles (RTU and system bottles) prior to every process run. Without this important information, risk of tissue damage or loss is possible. Therefore the missing information will be distributed to all customers by a Field Service Notice.
June 12, 2013Medical DevicesFDA
Leica Microsystems, Inc. recalls LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 140605469
Hazard: An LPC Fine Mesh Cassette failed to stay closed during processing operations.
December 19, 2012Medical DevicesFDA
Leica Microsystems, Inc. recalls Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro sta
Hazard: RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.
August 1, 2012Medical DevicesFDA
Leica Microsystems, Inc. recalls Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse,
Hazard: Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reduction can be observed when Leica M525 F50 surgical microscope is used in combination with a remote control connected to a remote video adapter or motorized dual video adapter.