Ventana BenchMark and Discovery Instruments Recalled for Heating Element Defect
Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect leading to inconsistent results rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Ventana Medical Systems is recalling the BenchMark XT/LT and Discovery XT instruments, including specific model numbers N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, and N750-DISXT-FS. The recall involves 1,217 units distributed worldwide, including the United States, Canada, Europe, Asia, and Japan.
The recall is initiated because there is a possibility that the heating element could separate from the underside of the heater cap. This defect may cause non-staining or inconsistent staining events. Additionally, the system may not detect this anomaly and therefore may not generate an error message for the slide position.
These instruments are intended to automatically stain histological or cytological specimens on microscope slides for in vitro diagnostic use, while the Discovery Systems are research use only instruments with similar functionality. Affected serial numbers are listed in the structured product information.
The recalled product
- Product
- Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with…
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 1,217
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- BenchMark XT Instruments-S/N: 711869-712465
Distribution
Distributed nationwide across the United States.
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