Agency classClass IIOur severity:High FDA (Devices)·Z-0833-2013·Announced 2013-08-14

Ventana BenchMark ULTRA Staining Platform Recalled for Fluid Overflow Risk

Ventana Medical Systems is recalling 1,735 BenchMark ULTRA automated staining platforms due to a potential waste fluid overflow that could cause electrical shorting.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shorting) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Ventana Medical Systems Inc is recalling 1,735 units of the BenchMark ULTRA automated staining platform (REF/MU 750-600). The recall also covers the DISCOVERY ULTRA automated staining platform. These instruments are intended for Research Use Only to automatically stain histological or cytological specimens on microscope slides.

The recall is due to a potential waste fluid overflow condition that can occur while running decontamination cycles. This overflow can lead to fluid migration across tubing and wiring within the instrument cabinet, resulting in contact with electrical circuitry. This contact may create shorting conditions.

The affected products were distributed worldwide, including nationwide in the USA and in Germany. Users should stop using the affected instruments and contact Ventana Medical Systems for further instructions.

The recalled product

Product: VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
Manufacturer: Ventana Medical Systems Inc
Category: Medical Device — Laboratory Equipment
Hazard: electrical-short
fluid-overflow
Affected units: 1,735

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 (20)

Cat#750-600
PN 05342716001
Serial #'s: 310724
310735
311187
312055
310373
311052
311171
311953
310750
311266
311267
311564
311565
311596
311304
310481
311924
310607

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ventana Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Ventana Medical Systems Inc

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Same hazard · electrical short