Reported Mar 7, 2018 · Terminated
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
Ventana Medical Systems Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventana Medical Systems Inc · 1910 E Innovation Park Dr · Oro Valley, AZ · 85755-1962
Is this the product you have?
ultraView SISH Detection KitVentana Part Number 780-001Roche GMMI 05271967001 in vitro diagnostic
- Lot codes and dates
- UDI 04015630972296
- Lot NumberY15133
- Amount recalled
- 6 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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