Leica Biosystems Richmond, Inc.
Richmond, IL, US
Leica Biosystems Richmond, Inc. appears in FDA device records in Richmond, IL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Leica Biosystems Richmond, Inc. in 2014.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1419341 | 1419341 | Leica Biosystems Richmond, Inc. | 5205 Us Highway 12, Richmond, IL 60071 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KEMAgent, Clearing
- JRGBlock, Heating
- IDZCassettes, Tissue
- KERContainer, Embedding
- NNIContainer, Specimen, Non-Sterile
- KESCoverslips, Microscope Slide
- HYBEosin Y
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- LDWFixative, Acid Containing
- LDZFixative, Alcohol Containing
- LDYFixative, Formalin-Containing
- IFJFixative, Richardson Glycol
- IGGFormaldehyde (Formalin, Formol)
- IFPFormalin, Neutral Buffered
- KEOFormulations, Paraffin, All
- IFZGelatin For Specimen Adhesion
- PPMGeneral Purpose Reagent
- HYJHematoxylin
- HYKHematoxylin Harris'S
- KEPMedia, Mounting, Oil Soluble
- KEQMedia, Mounting, Water Soluble
- KKMMethylene Blue Thiocyanate
- IDLMicrotome, Accessories
- HZHOrange G
- IERPolyethylene Glycol (Carbowax)
- LEAPreservative, Cytological
- KEWSlides, Microscope
- KDXSolution, Decalcifier, Acid Containing
- HZJStain, Papanicolau
- LEFStains, Dye Powder
- LEEStains, Dye Solution
- IZISystem, X-Ray, Angiographic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3126-2017 | 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 stained in qualitative immunohistochemistry (IHC) testing.. | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3125-2017 | 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 stained in qualitative immunohistochemistry (IHC) testing | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3124-2017 | 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-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3123-2017 | 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 autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC). | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3122-2017 | 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 identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3121-2017 | 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-embedded tissue stained in qualitative immunohistochemistry (IHC) testing. | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-3120-2017 | 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 sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods | A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements. | Class II | Terminated | |
| Z-1948-2016 | 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. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. | An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. | Class III | Terminated | |
| Z-2039-2016 | 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. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern. | Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated. | Class III | Terminated | |
| Z-1331-2012 | Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of preservative containing polyethylene glycol for the convenient collection, fixation and preservation of all cytologic specimens, 50 jars per case; for in vitro diagnostic use only; Leica Biosystems, 5205 Rt. 12, Richmond, IL 60071; Made in USA The Cyto Jar is for the convenient collection, fixation and preservation of all cytologic specimens. The 120 mL clear, leakproof container is prefilled with 45 mL of preservative containing polyethylene glycol. It can be used for rinsing aspiration needles or bronchial brushes and for the direct collection of sputum specimens. | Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for this product. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain