The Recall Desk

FDA (Devices) recall action 64244

Ventana Medical Systems Inc recalled 2 products on 2013-08-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-08-14
Critical
0
Units
1,789

Why these products were recalled

Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform. This type of overflow event can lead to migration of fluid across tubing and wiring within the instrument cabinet resulting in contact with electrical circuitry. This may create shorting conditions and u

Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the DISCOVERY ULTRA automated staining platform.The waste fluid drainage system may become restricted by build-up of debris in the tubing and in-line filter, thereby inhibiting optimal flow rates. This type of overflow event can lead to migration of flu

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··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.

    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 specific
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    0 states