Leica Microsystems recalls
Leica Microsystems appears in 40 official U.S. recall notices indexed by RecallRadar, most recently on 2022-12-21.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 40 |
|---|---|
| Published | 2012-08-01 to 2022-12-21 |
| By agency | FDA Device (40) |
| By classification | Class II (39), Class III (1) |
| By status | terminated (31), ongoing (9) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems
Reason: There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific componen… - Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems
Reason: There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific componen… - Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard)
FDA Device · Class II · 2022-12-21 · Leica Microsystems
Reason: There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific componen… - Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Device · Class II · 2022-10-05 · Leica Microsystems
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the softwa… - Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Device · Class II · 2022-10-05 · Leica Microsystems
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the softwa… - Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Device · Class II · 2022-10-05 · Leica Microsystems
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the softwa… - Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Device · Class II · 2022-10-05 · Leica Microsystems
Reason: During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the softwa… - Leica Microsystems M220 F12 Microscope Systems
FDA Device · Class II · 2021-12-29 · Leica Microsystems
Reason: In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some pote… - BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
FDA Device · Class II · 2021-09-22 · Leica Microsystems
Reason: Product may not perform as specified in IFU. - Leica ARveo and M530 OH6 microscope systems
FDA Device · Class II · 2020-06-24 · Leica Microsystems
Reason: Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage. - BOND Polymer Refine Detection Kit, Catalog No. DS9800
FDA Device · Class II · 2019-12-18 · Leica Microsystems
Reason: BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining. - Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic…
FDA Device · Class II · 2019-06-12 · Leica Microsystems
Reason: The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries. - PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination
FDA Device · Class II · 2019-02-27 · Leica Microsystems
Reason: The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of… - Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects…
FDA Device · Class II · 2019-01-30 · Leica Microsystems
Reason: The M220 optics may unintentionally drop into the surgical field, risking contact with the patient. - BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
FDA Device · Class II · 2018-11-07 · Leica Microsystems
Reason: The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound. - Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory…
FDA Device · Class II · 2018-10-10 · Leica Microsystems
Reason: These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power… - Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for me…
FDA Device · Class II · 2018-10-10 · Leica Microsystems
Reason: Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock. - Leica M525 F20 Surgical Microscope System
FDA Device · Class II · 2018-09-26 · Leica Microsystems
Reason: The firm received complaints that the instrument tipped over when the swing arm was fully extended. - Leica M530 OHX Microscope System Supplied with 100 - 120 Vac
FDA Device · Class II · 2018-08-15 · Leica Microsystems
Reason: Recall is due to a design weakness of the power insert module. - Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 1044…
FDA Device · Class II · 2018-08-01 · Leica Microsystems
Reason: Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. - Nussloch GmbH ASP6025 Tissue Processor
FDA Device · Class II · 2017-07-12 · Leica Microsystems
Reason: Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. - Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the…
FDA Device · Class II · 2016-06-08 · Leica Microsystems
Reason: Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. - Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues
FDA Device · Class II · 2016-06-08 · Leica Microsystems
Reason: Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling. - Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566
FDA Device · Class II · 2016-06-01 · Leica Microsystems
Reason: Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. - Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope
FDA Device · Class II · 2016-04-27 · Leica Microsystems
Reason: An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumi… - This reagent is for in vitro diagnostic use
FDA Device · Class II · 2016-03-02 · Leica Microsystems
Reason: The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied afte… - Bond Polymer Refine Red Detection DS9390 kits
FDA Device · Class II · 2016-02-24 · Leica Microsystems
Reason: The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate s… - Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10)
FDA Device · Class II · 2015-12-02 · Leica Microsystems
Reason: These Lot numbers are not stable up to the expiry date on the product labeling. - The Leica ASP6025 Tissue Processor
FDA Device · Class II · 2015-09-30 · Leica Microsystems
Reason: The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 li… - The Leica ASP200S/ASP300S Tissue Processor
FDA Device · Class III · 2015-09-23 · Leica Microsystems
Reason: The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. - Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining
FDA Device · Class II · 2015-04-01 · Leica Microsystems
Reason: The staining intensity decreases over the shelf life. - Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered salin…
FDA Device · Class II · 2014-11-12 · Leica Microsystems
Reason: 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… - Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes
FDA Device · Class II · 2014-06-18 · Leica Microsystems
Reason: 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). - Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope
FDA Device · Class II · 2014-06-18 · Leica Microsystems
Reason: 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). - Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative
FDA Device · Class II · 2014-06-11 · Leica Microsystems
Reason: 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. - Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant
FDA Device · Class II · 2014-06-11 · Leica Microsystems
Reason: 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… - Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation,…
FDA Device · Class II · 2013-08-07 · Leica Microsystems
Reason: 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 wit… - LPC Fine Mesh Cassette for the Leica LPC Printer
FDA Device · Class II · 2013-06-12 · Leica Microsystems
Reason: An LPC Fine Mesh Cassette failed to stay closed during processing operations. - Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent
FDA Device · Class II · 2012-12-19 · Leica Microsystems
Reason: RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity. - Leica M525 F50 Surgical Microscope
FDA Device · Class II · 2012-08-01 · Leica Microsystems
Reason: 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 rem…