Events

Recall of MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER HP PROLIANT ML350-G6 IVD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA 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
    150235
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Under certain conditions myla software when connected to a vitek 2 system and to a laboratory information system (lis) allowing the re-use of speciment id prensents the potential to link a result from vitek 2 to the wrong patient and then upload those results to the lis.

Device

MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER HP PROLIANT ML350-G6 IVD
  • Model / Serial
    Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 416546 MASTER 4.0 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 415358 MASTER 3.2 CLI DL380 (Lot serial: Myla Clinical 3.X to 4.1 ML350); Model Catalog: 419072 CLINICAL V3.X TO V 4.1 ML350 SERVER (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 419071 CLINICAL V3.X TO V4.1 DL380 SERVER (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 416546 MASTER 4.0 CLINIC (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 415358 MASTER 3.2 CLI DL380 (Lot serial: Myla Clinical 3.X to 4.1 DL380); Model Catalog: 419072 CLINICAL V3.X TO V 4.1 ML350 SERVER (Lot serial: Myla Master DVD 4.1 Clinique); Model Catalog: 419071 CLINICAL V3.X TO V4.1 DL380 SERVER (Lot serial: Myla Master DVD 4.1 Clinique); Model Catalog: 417191 MASTER 4.1 CLINIC (Lot serial: Myla Master DVD 4.1 Clinique); Model C
  • Product Description
    MYLA SERVER HP PROLIANT DL380-G8 IVD MYLA SERVER
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.