Events

Recall of BIOTESTCELL -P3

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTER MEDICO.

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
    21622
  • Event Risk Class
    III
  • Event Initiated Date
    2012-09-13
  • 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
    The biotestcell p3 are reagent red blood cells with polyvalent antigens of three single blood donors packaged in 3 separate vials for the detection of red cell antiobodies. the manufacturer received one complaint about an incorrectly labeled vial within the package. normally the vials come numbered p1 p2 p3. in this case the package contained 1 bottle of p1 and 2 bottles of p2.

Device

BIOTESTCELL -P3
  • Model / Serial
    Model Catalog: 816 017 (Lot serial: 2225011)
  • Product Description
    BIOTESTCELL P3
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC