Device recall

Z-2716-2011: ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This…

FDA device recall · Class II · Ventana Medical Systems Inc

Key facts

Recall number (Z-number) Z-2716-2011
Recall event 58855
Product ultraView Universal DAB Detection Kit, Part number: 760-500 (05269806001) This detection kit is intended for in vitro diagnostic use. Ventana Medical Systems' (Ventana) iVIEW DAB Detection Kit is an indirect biotin streptavidin system for detecting mouse IgG, mouse IgM and rabbit primary antibodies…
Product code MYA
Recalling firm Ventana Medical Systems Inc
Recall class Class II
Status Terminated
Termination date Feb 10, 2012
510(k) numbers K984567, K990618
FEI number 1000125183

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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