Device recall event

Recall event 91148: Biomerieux Inc

FDA device recall · Class II · Open, Classified

Key facts

Recall event number 91148
Recalling firm Biomerieux Inc
Recall class Class II
Status Open, Classified
510(k) numbers K010363, K020748, K032399, K0404845, K040485, K040560, K040845, K041982, K071146, K091025, K102668, K121100 and 24 more

At a glance

  • 10–99 Recalled products (Z-numbers)
  • 10–99 Linked 510(k)s
  • 10–99 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