Device recall

Z-1013-2013: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For…

FDA device recall · Class II · Biomerieux Inc

Key facts

Recall number (Z-number) Z-1013-2013
Recall event 64327
Product bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Product code LTW
Recalling firm Biomerieux Inc
Recall class Class II
Status Terminated
Termination date Oct 30, 2013
FEI number 1950204

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

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