Device recall

Z-1321-2010: Agendia MammaPrint, Catalog Numbers MP01, MP US version 03

FDA device recall · Class II · Agendia Inc

Key facts

Recall number (Z-number) Z-1321-2010
Recall event 54930
Product Agendia MammaPrint, Catalog Numbers MP01, MP US version 03
Product code NYI
Recalling firm Agendia Inc
Recall class Class II
Status Terminated
Termination date Jun 18, 2010
510(k) numbers K062694
FEI number 3007297853

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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