Events

Safety Alert for IH-Com kit Full version

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BioRad.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-12-12
  • Event Date Posted
    2012-12-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121212c.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biorad ih-com kit full version it has come to our attention that medical device manufacturer, biorad, has initiated a field safety corrective action concerning ih-com kit full version (data management and result interpretation software), with product reference 009000. the affected software versions are 03.0.43 / 03.0.52 / 03.0.59. according to the manufacturer, in case of not interpretable results in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software does not include the reaction of this well (result code -30) when sending the results to the laboratory host. the issue can only occur if some specific conditions are met. the described issue could lead to the interpretation of the abo group only based on the results of the anti-a and anti-b wells without taking into account the result of the anti-ab well of the concerned id-cards. the analysis of this issue led to the conclusion that a residual risk exists for newborns for whom abo group is only determined through abc forward grouping (no reverse grouping performed). in the worst case scenario, a mixed field result (“dp”) in the anti-ab well in addition to a non detectable mixed field in the other wells (anti-a or anti-b), could lead to assigning a wrong abc group to the newborn based on the mother’s group. the manufacturer advises users to immediately implement protective measures as follows: ensure that the "second reading" option of ih-com is activated at least on discrepant results in case of "abo not interpretable" in ih-com due to a reaction "?" or "+/-"or "dp" in the anti-ab well, the operator must open the "abo" scrollbar and select manually "abo not interpretable" before saving and sending the result to the host. according to biorad, this issue will be permanently corrected through the deployment of the next ih-com software version. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 12 december 2012.

Device

IH-Com kit Full version
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BioRad IH-Com kit Full version
  • Manufacturer
    BioRad

Manufacturer

BioRad