Device recall

Z-0919-04: VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro…

FDA device recall · Class II · bioMerieux Inc

Key facts

Recall number (Z-number) Z-0919-04
Recall event 28872
Product VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
Product code LON
Recalling firm bioMerieux Inc
Recall class Class II
Status Terminated
Termination date Apr 18, 2005
FEI number 1950204

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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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