Events

Safety Alert for NeoBase Non-Derivatized Assay Solutions

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

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
    2015-03-02
  • Event Date Posted
    2015-03-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150302.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: perkinelmer neobase non-derivatized assay solutions medical device manufacturer, perkinelmer, has issued a medical device safety alert concerning its neobase non-derivatized assay solutions [product number: 3041-0020; lot number: 1063599401, 1063599501]. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. the manufacturer has become aware that some bottles used in the manufacturing of the neobase extraction solution (lots 634151 and 634247) and neobase flow solvent (lots 634152 and 634303), contained cardboard lint and red particles. bottles containing the aforementioned particles were used in the packaging of neobase non-derivatized assasy solutions kit lots 1063599401 and 1063599501. the particles can be visually detected by the human eye. according to the manufacturer, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 march 2015.

Device

NeoBase Non-Derivatized Assay Solutions
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: PerkinElmer NeoBase Non-Derivatized Assay Solutions
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer