Events

Safety Alert for Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, Saliva Collector

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

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
    2013-06-25
  • Event Date Posted
    2013-06-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130625a.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: instalert multi‐drug multi‐line twist screen test device and instalert doa multi‐drug multi‐line screen test device, saliva collector the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the saliva collector that is an accessory in the multi‐drug multi‐line twist screen test device and instalert doa multi‐drug multi‐line screen test device, manufactured by innovacon, inc. the affected kit lot numbers are doa3010115, doa3030337, doa3030682, doa3030529 and the affected lot numbers of the saliva collector are b121208, b130103, b130104, b130101. in certain lots, the sponge may become dislodged from the saliva collector handle prior to or during the oral fluid sample collection process. if the sponge becomes dislodged during the specimen collection process, the donor may inadvertently swallow the sponge which could present a choking risk. the manufacturer's investigation indicates that the sponge may become dislodged on approximately 5% of the saliva collectors from affected lots. to date, there have been no reports of individuals swallowing or choking on the sponge during use. the manufacturer advises the affected users to: gently pull the sponge while it is in the wrapper before using the saliva collectors for the lots specified above and ensure it remains firmly attached to the handle; immediately discard any saliva collectors if the sponge detaches from the handle; and ask for a replacement product if they are not willing to perform the inspection steps. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con286923 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 june 2013.

Device

Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line ...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, Saliva Collector
  • Manufacturer
    Innovacon

Manufacturer

Innovacon
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH