Device recall

Z-1580-2016: Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

FDA device recall · Class II · Hologic, Inc

Key facts

Recall number (Z-number) Z-1580-2016
Recall event 73747
Product Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Product code NUA
Recalling firm Hologic, Inc
Recall class Class II
Status Terminated
Termination date Aug 9, 2016
510(k) numbers K063787
FEI number 2024800

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

Browse all FDA device recalls (products)