Immunohistochemistry Reagents And Kits
FDA product code NJT · Class I (low risk) · 21 CFR 864.1860 · Hematology
according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
0510(k) clearances
0PMA approvals
80recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0745-2026 Class II | MPOX TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-2565-2025 Class II | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako…Their is the potential for weak staining which may result in false negative CD20 identification. | Agilent Technologies Denmark ApS | 08/11/2025Open, Classified |
| Z-2564-2025 Class II | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako…Their is the potential for weak staining which may result in false negative CD20 identification. | Agilent Technologies Denmark ApS | 08/11/2025Open, Classified |
| Z-2563-2025 Class II | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako…Their is the potential for weak staining which may result in false negative CD20 identification. | Agilent Technologies Denmark ApS | 08/11/2025Open, Classified |
| Z-2644-2024 Class II | Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDTheir is a potential for high background and off-target staining when using the monoclonal primary antibody… | Ventana Medical Systems, Inc. | 06/27/2024Open, Classified |
| Z-2481-2021 Class II | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375Product may not perform as specified in IFU. | Leica Microsystems, Inc. | 07/30/2021Terminated |
| Z-2311-2021 Class III | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is… | Cell Marque Corporation | 07/15/2021Open, Classified |
| Z-0673-2020 Class II | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in…BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified… | Leica Microsystems, Inc. | 11/18/2019Open, Classified |
| Z-2291-2020 Class II | 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection…Firm has identified product has no staining. If used, may result in invalid test results when used with… | Biocare Medical, LLC | 10/10/2019Terminated |
| Z-3015-2018 Class I | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3009-2018 Class I | VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3004-2018 Class I | ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3003-2018 Class I | ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3001-2018 Class I | iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-3000-2018 Class I | OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2999-2018 Class I | ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2998-2018 Class I | iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2997-2018 Class I | ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2996-2018 Class I | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… | Ventana Medical Systems Inc | 08/02/2018Terminated |
| Z-2360-2018 Class II | Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using…Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in… | Biocare Medical, LLC | 04/24/2018Terminated |
| Z-3198-2018 Class II | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag…Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two… | Biocare Medical, LLC | 03/15/2018Terminated |
| Z-0740-2018 Class I | NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0737-2018 Class I | OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0736-2018 Class I | OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0735-2018 Class I | CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0734-2018 Class I | CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0731-2018 Class I | iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0730-2018 Class I | ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-0729-2018 Class I | OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in…Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers… | Ventana Medical Systems Inc | 12/19/2017Terminated |
| Z-3126-2017 Class II | Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3125-2017 Class II | Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3124-2017 Class II | Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3123-2017 Class II | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3122-2017 Class II | Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3121-2017 Class II | Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-3120-2017 Class II | Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for…A delay in transit may have contributed to nonconformity as the product was stored outside of defined… | Leica Biosystems Richmond Inc. | 07/14/2017Terminated |
| Z-2038-2016 Class II | SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and…Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers… | Cell Marque Corporation | 05/10/2016Terminated |
| Z-1877-2016 Class II | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment…Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date… | Leica Microsystems, Inc. | 04/05/2016Terminated |
| Z-1876-2016 Class II | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is…Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the… | Leica Microsystems, Inc. | 04/05/2016Terminated |
| Z-1523-2016 Class III | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number…Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4… | Biocare Medical, LLC | 03/31/2016Terminated |
| Z-1704-2016 Class II | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for…Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of… | Leica Microsystems, Inc. | 03/22/2016Terminated |
| Z-0815-2016 Class III | CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. Description…Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250. | Lab Vision Corporation | 01/18/2016Terminated |
| Z-0823-2016 Class II | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended…The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining… | Leica Microsystems, Inc. | 12/30/2015Terminated |
| Z-0808-2016 Class II | Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is…The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the… | Leica Microsystems, Inc. | 11/27/2015Terminated |
| Z-0252-2016 Class II | Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml…Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically… | Biocare Medical, LLC | 09/08/2015Terminated |
| Z-0341-2016 Class II | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in…These Lot numbers are not stable up to the expiry date on the product labeling. | Leica Microsystems, Inc. | 09/03/2015Terminated |
| Z-1676-2015 Class III | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product…Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. | Biocare Medical, LLC | 05/06/2015Terminated |
| Z-1535-2015 Class II | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides…A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. | Biocare Medical, LLC | 03/17/2015Terminated |
| Z-1315-2015 Class II | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform…The staining intensity decreases over the shelf life. | Leica Microsystems, Inc. | 12/16/2014Terminated |
| Z-0965-2015 Class II | MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In…Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has… | Biocare Medical Llc | 12/12/2014Terminated |