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Recall Observatory FDA recall evidence

Device product

OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

Z-0736-2018

December 19, 2017

Class I

Product summary

Firm
Ventana Medical Systems Inc
Event
Event 78942
Status
Terminated
Classification
Class I
Quantity
5040 units
Official record key
device-enforcement:Z-0736-2018

Official wording

Reason: 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.

Code information: UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447

Distribution pattern: 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,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.