Events

Recall of RHD BEADCHIP KIT

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

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
    19902
  • Event Risk Class
    III
  • Event Initiated Date
    2016-02-11
  • 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
    Bioarray solutions ltd. has determined that rhd master lot 16-166 has incorrect error cutoff values. lot-specific error cutoff values for the rhd snp markers released into the basis global software for rhd master lot 16-166 can create indeterminate genotype calls ("xx") which may impact the accuracy of the variant allele calls.

Device

RHD BEADCHIP KIT
  • Model / Serial
    Model Catalog: 800-10220-48 (Lot serial: 16-166)
  • Product Description
    BioArray Solution's RHD BeadChip Kit
  • Manufacturer
    BIOARRAY SOLUTIONS LTD.

Manufacturer

BIOARRAY SOLUTIONS LTD.
  • Manufacturer Address
    WARREN
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC