The Recall Desk

Manufacturer

Leica Microsystems, Inc.

40 recalls in our database name Leica Microsystems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
40
Critical
0
Severe
2
Most recent
2022-12-21

Of the 40 recalls from Leica Microsystems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–40 of 40

  • ModerateFDA (Devices)·Z-0823-2016·2016-03-02

    Leica Bond Polymer Refine Detection System Recalled for Inadequate Staining

    Leica Microsystems is recalling the Bond Polymer Refine Detection System because it may not provide adequate staining when used with specific protocols.

    Product
    This 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.
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0808-2016·2016-02-24

    Leica Bond Polymer Refine Red Detection Kits Recalled for Staining Errors

    Leica Microsystems is recalling Bond Polymer Refine Red Detection kits due to a manufacturing error that may cause inadequate staining.

    Product
    Bond 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 fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2016·2015-12-02

    Leica Microsystems Recalls Unstable CD10 Monoclonal Antibody Diagnostic Reagents

    Leica Microsystems is recalling specific lots of Novocastra CD10 antibody reagents because they are not stable up to the labeled expiry date.

    Product
    Novocastra 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2804-2015·2015-09-30

    Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling

    Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.

    Product
    The 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.
    Category
    Medical Device
    Distribution
    34 states
  • LowFDA (Devices)·Z-2779-2015·2015-09-23

    Leica ASP200S/ASP300S Tissue Processor Recall for Wiring Defect

    Leica Microsystems is recalling 901 tissue processors due to incorrect internal wiring that may prevent remote alarms from functioning during instrument failure.

    Product
    The 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.
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-1315-2015·2015-04-01

    Leica CD15 Antibody Recalled for Decreasing Staining Intensity

    Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.

    Product
    Liquid 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 sta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (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.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-1725-2014·2014-06-18

    Leica Ceiling Mount MSF-1 Recalled Due to Broken Drive Screw

    Leica Microsystems is recalling 103 MSF-1 ceiling mounts because a broken drive screw caused the lift arm to fall approximately 60 cm.

    Product
    Leica 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 magnificatio
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1726-2014·2014-06-18

    Leica Ceiling Mounts Recalled Due to Broken Drive Screw

    Leica Microsystems is recalling 103 ceiling mounts for M500 N microscopes because a broken drive screw caused the lift arm to fall approximately 60 cm.

    Product
    Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnifica
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1698-2014·2014-06-11

    Leica Monoclonal Antibody Recalled for Reduced Functionality

    Leica Microsystems is recalling Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi because it does not function as intended up to the expiry date.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1710-2014·2014-06-11

    Leica CD15 Antibody Recalled for Reduced Function Before Expiration

    Leica Microsystems is recalling 145 units of CD15 antibody that may not function as intended before the expiration date due to age-related staining issues.

    Product
    Liquid 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1815-2013·2013-08-07

    Leica ASP6025 Vacuum Tissue Processor Recalled for Incorrect Bottle Dimensions

    Leica Microsystems is recalling 128 ASP6025 tissue processors because the manual lists incorrect dimensions for third-party bottles, risking reagent contamination and tissue loss.

    Product
    Leica 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1446-2013·2013-06-12

    Leica Microsystems Recalls LPC Fine Mesh Cassettes for Closure Failure

    Leica Microsystems is recalling LPC Fine Mesh Cassettes because they failed to stay closed during processing operations. The recall affects 20,160 units distributed in the US and New Zealand.

    Product
    LPC 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0521-2013·2012-12-19

    Leica TdT Staining Reagent Recalled for Stability Issues

    Leica Microsystems is recalling 322 vials of Novocastra TdT Staining Reagent because the product is not stable up to its expiry date, affecting staining intensity.

    Product
    Novocastra 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-Td
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2053-2012·2012-08-01

    Leica M525 F50 Surgical Microscope Recalled for Illumination Malfunction

    Leica Microsystems is recalling M525 F50 surgical microscopes because a malfunction can cause reduced illumination when used with specific remote control adapters.

    Product
    Leica 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
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Leica Microsystems

company

Country
Germany
Founded
1997

Official website

Source: Wikidata (Q880935), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.