Recall of ZYMUTEST HIA IGGAM

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

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
    122610
  • Event Risk Class
    III
  • Event Initiated Date
    2017-11-20
  • Event Country
  • 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
    We received one us customer complaint related to negative control out of range for zymutest hia iggam rk040d lot f1700415. subsequent investigation of this lot produced 2 false positive results. zymutest hia monostrip iggam rk041d lot 1700416 is also impacted as some components are common to both lots. use of these lots may produce false positive results.

Device

  • Model / Serial
    Model Catalog: RK040D (Lot serial: F1700416); Model Catalog: RK040D (Lot serial: F1700415); Model Catalog: RK041D (Lot serial: F1700416); Model Catalog: RK041D (Lot serial: F1700415)
  • Product Description
    ZYMUTEST HIA IGGAM
  • Manufacturer

Manufacturer

  • Manufacturer Address
    NEUVILLE SUR OISE
  • Manufacturer Parent Company (2017)
  • Source
    HC