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Ventana Medical Systems, Inc. FDA Recalls
5 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. Material Class IIApr 20, 2026Due to complaints received for the Image Management System r |
| Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDClass IIJun 27, 2024Their is a potential for high background and off-target stai |
| VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVClass IINov 18, 2022Internal comparison studies revealed unacceptable, light sta |
| Ventana HE 600 System, automated slide preparer, for use in laboratories.Class IIJun 1, 2022There is a potential for fluid leak inside the Ventana HE 6 |
| BenchMark ULTRA and DISCOVERY ULTRA InstrumentsClass IIJan 20, 2022Potential for Fluid Leak inside a staining system that could |