The Recall Desk

FDA (Devices) recall action 77799

Biomerieux Inc recalled 2 products on 2017-09-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2017-09-06
Critical
0
Units
11,100

Why these products were recalled

Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

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.

1–2 of 2

  • ModerateFDA (Devices)··2017-09-06

    BioMérieux Recalls VITEK 2 Compact 30 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 30 software and reagent cards because a software update prevents test cards from finalizing results, potentially disrupting laboratory processing.

    Product
    VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-09-06

    BioMérieux Recalls VITEK 2 Compact 15 Software and Reagent Cards

    BioMérieux is recalling VITEK 2 Compact 15 software and reagent cards because they may fail to finalize test results after a software update.

    Product
    VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.
    Category
    Distribution
    0 states