The Recall Desk

FDA (Devices) recall action 70868

Biomerieux Inc recalled 3 products on 2015-05-20

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
2015-05-20
Critical
0
Units
—

Why these products were recalled

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

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

1–3 of 3

  • ModerateFDA (Devices)··2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.

    Product
    Vitek 2 AST-YS01 REF 22 108, Fungal 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 clinically significant yeasts to antifungal agents when used as…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produced Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS06 REF 412 610, Fungal 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 clinically significant yeasts to antifungal agents when used as…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-05-20

    Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS07 REF 414 967, Fungal 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 clinically significant yeasts to antifungal agents when used as…
    Category
    Distribution
    0 states