The Recall Desk

Manufacturer

Leica Biosystems Richmond Inc.

9 recalls in our database name Leica Biosystems Richmond Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2017-09-20

Of the 9 recalls from Leica Biosystems Richmond Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–9 of 9

  • ModerateFDA (Devices)·Z-3120-2017·2017-09-20

    Leica Biosystems Recalls Podoplanin Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling four units of Podoplanin (D2-40 Mab) antibody because a delay in transit may have caused the product to be stored outside of required temperature limits.

    Product
    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3123-2017·2017-09-20

    Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.

    Product
    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autoso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3124-2017·2017-09-20

    Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3122-2017·2017-09-20

    Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.

    Product
    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively ident
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3126-2017·2017-09-20

    Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion

    Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue staine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3121-2017·2017-09-20

    Leica Biosystems Recalls Glypican-3 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling three units of Glypican-3 (1G12 Mab) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.

    Product
    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3125-2017·2017-09-20

    Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation

    Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.

    Product
    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2039-2016·2016-06-29

    Leica Biosystems Recalls CytoVision Systems Due to Windows 7 Activation Issues

    Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.

    Product
    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1948-2016·2016-06-22

    Leica Biosystems Recalls Ariol Automated Scanning Microscopes Due to Software Issue

    Leica Biosystems Richmond Inc. is recalling 33 Ariol automated scanning microscope systems because a manufacturing error resulted in an improperly activated Windows 7 operating system.

    Product
    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. Thi
    Category
    Medical Device
    Distribution
    Distributed nationwide