Events

Recall of SYNCHRON SYSTEMS HYDROXYBUTYRATE DEHYDROGENASE REAGENT (HBDH)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    116371
  • Event Risk Class
    III
  • Event Initiated Date
    2004-08-16
  • 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
    May be some assay recovery differences between the stand-alone access 2 immunoassay and the access 2i.

Device

SYNCHRON SYSTEMS HYDROXYBUTYRATE DEHYDROGENASE REAGENT (HBDH)
  • Model / Serial
    Model Catalog: (Lot serial: Device ID 195413); Model Catalog: (Lot serial: Device ID 195412); Model Catalog: (Lot serial: Device ID 185558)
  • Product Description
    SYNCHRON LXi 725
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.