Ventana Medical Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
41 (33 Class I)
510(k) Clearances
49
Inspections
14
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2644-2024Class IIVentana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDJune 27, 2024
Z-0907-2023Class IIVENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 November 18, 2022
Z-1374-2022Class IIVentana HE 600 System, automated slide preparer, for use in laboratories.June 1, 2022
Z-0894-2022Class IIBenchMark ULTRA and DISCOVERY ULTRA InstrumentsJanuary 20, 2022
Z-2262-2020Class IIModel Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environOctober 4, 2019
Z-3008-2018Class IVENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 ImmunohistochemiAugust 2, 2018
Z-3006-2018Class ICONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 052August 2, 2018
Z-3000-2018Class IOptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 ImmunohistochemAugust 2, 2018
Z-3015-2018Class INEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 ImmunohistocheAugust 2, 2018
Z-2998-2018Class IiView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for iAugust 2, 2018
Z-3016-2018Class IultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IAugust 2, 2018
Z-3004-2018Class IultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-50August 2, 2018
Z-2997-2018Class IultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 ImmunohistochemAugust 2, 2018
Z-3005-2018Class IISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitAugust 2, 2018
Z-3014-2018Class IINFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 ImmunohistochAugust 2, 2018
Z-3003-2018Class IANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 ImmunohistoAugust 2, 2018
Z-2996-2018Class IOptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IAugust 2, 2018
Z-2999-2018Class IultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 ImmunohistochemistAugust 2, 2018
Z-3001-2018Class IiView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For lAugust 2, 2018
Z-3007-2018Class ICONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 0527841August 2, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K242783Roche Digital Pathology DxDecember 17, 2024
DEN240025VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)December 5, 2024
K232879Roche Digital Pathology Dx (VENTANA DP 200)June 14, 2024
K212176CINtec HistologyDecember 10, 2021
K172471VENTANA CD30 (Ber-H2) RxDx AssayMay 8, 2018
DEN170030VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse MonoclonalOctober 27, 2017
DEN160019CINtec Histology (50 tests), CINtec Histology (250 tests)March 4, 2017
K142965Virtuoso System for IHC PR (1E2) using iScan HTJuly 16, 2015
K140465VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINERMarch 20, 2014
K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)November 22, 2013
K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)September 26, 2013
K122143VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERSeptember 19, 2013
K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)September 6, 2013
K110215CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODYDecember 17, 2012
K121350VIRTUSO SYSTEM FOR IHC (DO-7)June 1, 2012
K111872VIRTUOSO SYSTEM FOR IHC P53 (DO-7)April 19, 2012
K111869VIRTUOSO SYSTEM FOR IHC PR (IE2)March 5, 2012
K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)February 22, 2012
K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)October 12, 2011
K101234VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYAugust 25, 2011