Events

Recall of Biomerieux Vitek2 AST-YS07 Test Kits

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by BioMerieux Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18488
  • Event Initiated Date
    2015-05-21
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    An issue related to out-of-range-low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258, the package insert qc strain, has been identified in association with the vitek 2 ast-ys06 and ast-ys07 test kits., internal investigation at the manufacturing site has observed the oorl fct qc results for candida krusei atcc 6258. internal testing of fct with additional isolates shows a trend to call one to two doubling dilutions low. candida krusei are intrinsically resistant to fct and are therefore forced "resistant" in vitek 2 software (as of version 7.01); the vitek® 2 7.01 fct forcing rule does not apply to other candida species. user reports have been limited to the atcc 6258 qc strain; however, impact to patient results for candida krusei and other yeast cannot be ruled out.
  • Action
    Manufacturer to issue advice regarding use

Device

Biomerieux Vitek2 AST-YS07 Test Kits
  • Model / Serial
    Model: Catalogue numbers: 414967, Affected: Lot numbers: 287314910, 287317310, 287323520, 287336220, 287340140
  • Manufacturer
    BioMerieux Inc

Manufacturer

BioMerieux Inc