Events

Safety Alert for Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials

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

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
    2012-05-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120521a.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: abbott molecular vysis fish pretreatment reagent kits, paraffin pretreatment reagent kits & protease vials medical device manufacturer, abbott molecular incorporation, has issued an field advisory notice concerning the vysis fish pretreatment reagent kit, [list number 02j03-032]; vysis paraffin pretreatment reagent kit, [list number 02j02-032]; paraffin pretreatment reagent kit ii, [list number 07j02-002]; protease i, 250mg x 2 vials, [list number 02j08-032] respectively. the manufacturer identified protease vials that were under filled and over filled. this may result in under or over digestion of the specimens and controls. according to the manufacturer, under or over digestion of specimens or controls could cause fish assays to be difficult to interpret or produce invalid/uninformative results. an invalid/uninformative control slide or specimen slide would result in the need to perform a repeat analysis with fresh control slides and specimen slide(s). there is no impact on results generated for slides that produce valid and interpretable results. according to the local supplier, the affected devices were distributed in hong kong. for details, please refer to the attached field advisory notice. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Abbott Molecular Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials
  • Manufacturer
    Abbott Molecular Incorporation

Manufacturer

Abbott Molecular Incorporation
  • 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