Events

Safety Alert for 10% Neutral Buffered Formalin

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Thermo Scientific Richard-Allan Scientific.

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
    2014-10-17
  • Event Date Posted
    2014-10-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141017.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: thermo scientific richard-allan scientific 10% neutral buffered formalin the u.S. food and drug administration (fda) posted a medical device safety alert concerning 10% neutral buffered formalin (nbf), manufactured by thermo scientific richard-allan scientific. the product details are as follows: cardinal health prefilled buffered 10% formalin (product code: c4320-450b; lot no.: 300403); richard-allan scientific specimen transportation system (product code: 53151 and 534801; lot no.: 300143 and 296986); richard-allan scientific 10% nbf (product code: 51401 and lc-0060; lot no.: 300649 and 300445); richard-allan scientific bio-tite specimen containers (product code: 59601; lot no.: 300233); protocol 10% nbf product (product code: 426-796; lot no.: 298987) the affected lots could have nbf concentrations that are lower or higher than the desired specifications. for details, please refer to the fda website http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=69276&w=10152014??eng if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 17 october 2014.

Device

10% Neutral Buffered Formalin

Manufacturer

Thermo Scientific Richard-Allan Scientific