Events

Recall of MICRO TYPING SYSTEM (MTS) - A/B/D MONOCLONAL & REVERSE GROUPING CARD

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    50231
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-07
  • 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
    Ocd observed an increased number of complaints related to false positive and/or reactions containing haze in the anti-a and buffered gel microtubes used for reverse abo typing in the mts a/b/d monoclonal and reverse grouping card lots listed above. our investigation determined that the false positive reactions were due to broken gel beads in the microtubes of the mts cards.

Device

MICRO TYPING SYSTEM (MTS) - A/B/D MONOCLONAL & REVERSE GROUPING CARD
  • Model / Serial
    Model Catalog: MTS080515 (Lot serial: 02413037-53); Model Catalog: MTS080515 (Lot serial: 120213037-55)
  • Product Description
    BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS