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VENTANA HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc. · Model 08314365001 · UDI-DI 07613336158432

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510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2017-05-05	Cell Marque Corporation	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requir
2017-05-05	Cell Marque Corporation	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as requir
2016-06-10	Dako North America Inc.	An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
2014-01-21	Dako North America Inc.	Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed.
2013-05-13	Life Technologies Corporation	Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.
2011-11-14	Life Technologies Corporation	In vitro diagnostic reagent may be contaminated with a fungal contaminant.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.