Device recall

Z-0654-03: Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096

FDA device recall · Class II · Digene Corp

Key facts

Recall number (Z-number) Z-0654-03
Recall event 25678
Product Digene''s Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096
Product code MAQ
Recalling firm Digene Corp
Recall class Class II
Status Terminated
Termination date Jul 16, 2003
PMA numbers P890064, P890064S006
FEI number 3003572099

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)