Device recall event

Recall event 76201: BioMerieux SA

FDA device recall · Class II · Terminated

Key facts

Recall event number 76201
Recalling firm BioMerieux SA
Recall class Class II
Status Terminated
510(k) numbers K081325, K102668, K913459, K960989, K971694, K980345, K980348, K981135, K981136, K981138

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