Ventana Medical Systems Inc

Complete recall history across all FDA and CPSC categories — 39 total recalls

Ventana Medical Systems Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (39)

FDA medical device enforcement actions by Ventana Medical Systems Inc

Date Product Reason Class
Jun 1, 2022 Ventana HE 600 System, automated slide preparer, for use in laboratories. There is a potential for fluid leak inside the Ventana HE 600 instrument whi... Class II
Jan 20, 2022 BenchMark ULTRA and DISCOVERY ULTRA Instruments Potential for Fluid Leak inside a staining system that could cause an electri... Class II
Oct 4, 2019 Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System... The firm became aware of a cleaning solution leaking issue from the middle st... Class II
Aug 2, 2018 OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 ... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 ... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 ... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody,... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 ... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immun... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 7... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-09... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antib... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 76... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistoche... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohi... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, M... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-0... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 7... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohis... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, ... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Aug 2, 2018 INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 80... Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) disp... Class I
Dec 19, 2017 ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 0527196... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMM... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI ... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 063965180... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 059... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche G... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche ... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitr... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Dec 19, 2017 ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GM... Increased reports of leaking and sticking reagent dispensers for horseradish ... Class I
Sep 28, 2012 VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... Potiential for a waste fluid overflow condition to accur while running decont... Class II
Sep 28, 2012 VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Resear... Potential for a waste fluid overflow condition to accur while running deconta... Class II
Jun 12, 2008 Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS... Ventana Medical System is initiating the recall of the BenchMark and DISCOVER... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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