The Recall Desk
HighFDA (Devices)·Z-0834-2013·Announced 2013-08-14

Ventana Discovery Ultra Staining Systems Recalled for Waste Fluid Overflow Risk

Ventana Medical Systems is recalling 54 Discovery Ultra automated staining systems because waste fluid drainage may become restricted, leading to overflow and potential fluid migration.

What this means for you

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 is classified as FDA Class II, and the hazard involves a risk of harm (fluid migration/overflow) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Ventana Medical Systems Inc is recalling 54 units of the DISCOVERY ULTRA automated staining platform (REF/MU 750-601). The recall is due to a potential waste fluid overflow condition that can occur while running decontamination cycles. The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, which inhibits optimal flow rates.

This overflow event can lead to the migration of fluids. The affected products were distributed worldwide, including nationwide in the USA and in Germany. The recall covers specific serial numbers listed in the agency documentation.

Consumers and researchers should stop using the affected instruments and contact Ventana Medical Systems for further instructions on remediation or replacement.

The recalled product

Product
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; 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 specific
Manufacturer
Ventana Medical Systems Inc
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
54

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#750-601
  • PN 05987750001
  • Serial #'s: 310646
  • 311573
  • 310477
  • 311725
  • 311042
  • 311623
  • 312032
  • 312159
  • 310615
  • 310837
  • 311862
  • 311043 311572
  • 311766
  • 310526
  • 311011
  • 311185
  • 311723
  • 312082

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 →

Related recalls

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Same hazard · fluid overflow

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