The Recall Desk

FDA (Devices) recall action 70645

Biomerieux Inc recalled 3 products on 2015-04-15

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2015-04-15
Critical
0
Units
13,967

Why these products were recalled

The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • LowFDA (Devices)··2015-04-15

    Biomerieux Recalls Vitek 2 AST-P641 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P641 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2015-04-15

    Biomerieux Recalls Vitek 2 AST-P640 Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P640 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended use organism.

    Product
    Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2015-04-15

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Cards Due to Labeling Error

    Biomerieux Inc is recalling Vitek 2 AST-P635 Gram Positive Susceptibility Cards because the packaging incorrectly lists Streptococcus pneumoniae as an intended organism.

    Product
    Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
    Category
    Distribution
    0 states