Events

Safety Alert for MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%

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

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
    2017-12-18
  • Event Date Posted
    2017-12-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171218.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: greiner bio-one minicollect complete 1ml 9nc coagulation sodium citrate 3.2% medical device manufacturer, greiner bio-one, has issued a medical device safety alert concerning its minicollect complete 1ml 9nc coagulation sodium citrate 3.2% [item number: 450556; lot number: a17083kp; expiry date: 19 february 2019]. the manufacturer became aware that the affected product partly showed not enough additive which might cause falsification of analysis results, if the collected blood sample was used for analysis. the affected users are instructed to send back all products of the affected item or verifiably scrap the products and confirm the scrapping to the manufacturer. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 december 2017.

Device

MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Greiner Bio-One MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%
  • Manufacturer
    Greiner Bio-One

Manufacturer

Greiner Bio-One