CLASS I Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

ultraView SISH Detection Kit, Ventana recalled

Ventana Medical Systems is recalling ultraView SISH Detection Kit, Ventana, distributed nationwide in the US. The recall was initiated on 19 Dec 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI 04015630972296, Lot Number: Y15133

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0732-2018
FDA event ID: 78942
Recalling firm: Ventana Medical Systems, Oro Valley, AZ
Classification: Class I
Status: Terminated
Recall initiated: 19 Dec 2017
FDA classified: 14 Sep 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Test Kits & Diagnostics

Timeline

19 Dec 2017	Recall initiated by company
7 Mar 2018	Published in enforcement report	+78 days
14 Sep 2018	Classified by FDA	+191 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

Where it was distributed

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI 04015630972296, Lot Number: Y15133

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 78942

This product is part of a recall event; the main page for the event is ultraView Universal DAB Detection Kit, Ventana recalled.

Reported	Class	Recall	Company	Reason	Where
7 Mar 2018	CLASS I	ultraView Universal DAB Detection Kit, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	Hematoxylin II, Ventana recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	iView DAB IHC Detection Kit, Ventana recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	Nexes Ven Iview Dab Det KT Jpn-us Export, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	CINtec PLUS Cytology Kit (Canada/Japan), Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	ultraView SISH DNP Detection Kit, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	OptiView Amplification Kit, Ventana recalled by Ventana Medical Systems	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	ultraView SISH DNP Detection Kit US, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	CINtec Plus Cytology Kit (Ce-ivd), Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	OptiView Amplification Kit (250 Test), Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide
7 Mar 2018	CLASS I	OptiView DAB IHC Detection Kit, Ventana recalled	Ventana Medical Systems	Packaging Defects	Nationwide

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All 42

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