Oro Valley, AZ, United States
Ventana Medical Systems Inc recalls
8 recalls recorded since 2018, most recently on 20 April 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)5
Terminated or completed3
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 20 April 2026
- Reason
- Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, WI, and WV. The countries of Austria, Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2913-2026
- navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Number 09453733001 UDI-DI Code: 761333602095AQ In the United States, navify Digital Patholog
Ongoing Class II Medical devices
- Recall started
- 27 June 2024
- Reason
- Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Austria, Bel
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2644-2024
- Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Ongoing Class II Medical devices
- Recall started
- 18 November 2022
- Reason
- Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, Austria, Belgium, Croatia, Cyprus, Cze
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0907-2023
- VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
Ongoing Class II Medical devices
- Recall started
- 1 June 2022
- Reason
- There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
- Distribution
- US: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ NY OH OK OR PA PR SC SD TN TX UT VA WA WI WV OUS: Canada, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1374-2022
- Ventana HE 600 System, automated slide preparer, for use in laboratories.
Ongoing Class II Medical devices
- Recall started
- 20 January 2022
- Reason
- Potential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1 Connector that could result in smoke and fire.
- Distribution
- US: CA, IL, PA, FL, AZ, NY, OH, CO, AR, NC, MD, AL, AK, LA, IA, MN, MA, ND, IN, TX, TN, CT, SC, GA, UT, WI, VA, SD, KY, MS, MO, DE, MI, MT, NJ, WV, OK, WA, OR, PR, DC, NM, ID, NH, NE, ME, KS, HI, NV, RI, WY, VT OUS: Australia, Austria, Belgium, Canada, China, Croatia, Denmark, Finland, France, Ge
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0894-2022
- BenchMark ULTRA and DISCOVERY ULTRA Instruments
Completed Class II Medical devices
- Recall started
- 4 October 2019
- Reason
- The firm became aware of a cleaning solution leaking issue from the middle staining module of the Ventana HE 600 instrument, used for histologic section samples in anatomic pathology laboratory settings, which caused fluid to travel down to the electrical wiring connector of the Coverslipper solvent shield circuit board. This can cause an electrical short and result in burned components.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MD, MI, MA, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2262-2020
- Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or priva
Terminated Class I Medical devices
- Recall started
- 2 August 2018
- Terminated
- 22 November 2021
- Reason
- Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3014-2018, Z-3010-2018, Z-2998-2018, Z-3003-2018, Z-3008-2018, Z-3001-2018, Z-3011-2018, Z-3005-2018, Z-3015-2018, Z-3006-2018, Z-2999-2018, Z-3000-2018 and 9 more
- INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
- VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
- iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
- ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
- VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
- iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
- CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
- ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
- and 13 more product lines
Terminated Class I Medical devices
- Recall started
- 19 December 2017
- Terminated
- 22 November 2021
- Reason
- Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
- Distribution
- Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0730-2018, Z-0738-2018, Z-0731-2018, Z-0740-2018, Z-0735-2018, Z-0739-2018, Z-0736-2018, Z-0733-2018, Z-0734-2018, Z-0737-2018, Z-0729-2018, Z-0732-2018
- ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
- Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
- iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
- NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
- CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
- ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
- OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
- ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
- and 4 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.