Device recall

Z-0842-2014: API Listeria (REF 10300) API Listeria is a standardized system for the…

FDA device recall · Class II · Biomerieux France Chemin De L'Or

Key facts

Recall number (Z-number) Z-0842-2014
Recall event 66931
Product API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical…
Recalling firm Biomerieux France Chemin De L'Or
Recall class Class II
Status Terminated
Termination date Nov 30, 2017
FEI number 1000611339

At a glance

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

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)