Events

Recall of AUTOSTAINER 48 LINK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGILENT TECHNOLOGIES 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
    80208
  • Event Risk Class
    II
  • Event Initiated Date
    2015-02-24
  • 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
    A leaking stopcock spare part (922640 rev.02) used in the autostainer isntrument family has been obersved. feedback from service engineers indicate that the stopcock component of the syringe assembly is leaking around the plunger in the stopcock when the prove is being washed/flushed. this could result in a reduced intensity score giving a false negative result in harceptest but does not affect the clinical outcome of any other reagents.

Device

AUTOSTAINER 48 LINK
  • Model / Serial
    Model Catalog: AS480 (Lot serial: AS48-0363-01); Model Catalog: AS480 (Lot serial: AS2041D1106); Model Catalog: AS480 (Lot serial: AS2042D1106); Model Catalog: AS480 (Lot serial: AS2044D1106); Model Catalog: AS480 (Lot serial: all lots. contact mfg); Model Catalog: AS480 (Lot serial: AS1474D0910); Model Catalog: AS480 (Lot serial: AS2040D1106); Model Catalog: AS480 (Lot serial: AS1766D1010); Model Catalog: AS480 (Lot serial: AS48-0204-01); Model Catalog: AS100 (Lot serial: all lots. contact mfg); Model Catalog: S3800 (Lot serial: all lots. contact mfg); Model Catalog: S3400 (Lot serial: all lots. contact mfg)
  • Product Description
    Autostainer 48 Link
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.