Device recall event

Recall event 56775: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA

FDA device recall · Class II · Terminated

Key facts

Recall event number 56775
Recalling firm Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
Recall class Class II
Status Terminated

At a glance

  • 1–9 Recalled products (Z-numbers)
  • None Linked 510(k)s
  • 1–9 Recall events for this firm

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

About FDA device recall events

A recall event groups every recalled product (Z-number) from one recall action by a firm. Class I recalls involve a reasonable probability of serious harm; Class III recalls are unlikely to cause harm.

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

Browse all FDA device recall events