A Chinese-made mask approved by Health Canada is the subject of a counterfeit warning issued by the Centers for Disease Control in the U.S.
A Chinese-made mask approved by Health Canada is the subject of a counterfeit warning issued by the Centers for Disease Control and Prevention in the U.S.
The Associated Press has reported that counterfeit masks, intended to mimic medical-grade N95 masks made by the Shanghai Dasheng company and approved for use in Canada, already have been distributed to front-line medical staff at some U.S. hospitals.
And a separate Chinese mask maker also licensed by Health Canada has seen its approval pulled by the Food and Drug Administration in the United States.
The Guangdong Golden Leaves Technology Development Co. Ltd. was one of 65 Chinese manufacturers whose authorization to sell in the U.S. was withdrawn following tests by the Centers for Disease Control (CDC).
The manufacturer remains approved in Canada, but its product has not been distributed to health care workers here, a spokesperson for Public Services and Procurement Canada told CBC News.
Both cases illustrate the difficulties faced by governments in trying to procure reliable masks when a flood of fake, shoddy and deceptively-labelled products is pouring out of China.
Fake numbers proliferating
All masks approved for use in U.S. hospitals must have a Testing and Certification (TC) number issued by the National Institute for Occupational Safety and Health. The CDC has warned that the TC number issued to the Shanghai Dasheng Co. for its masks — TC 84A-4329 — has been misappropriated by other Chinese makers seeking to sell substandard products in the U.S. market.
U.S. government agencies like the National Park Service have been warning their workers to watch out for the fake masks.
Health Canada approved Shanghai Dasheng’s DTC3X N95 masks by interim order on April 27. That interim order process has been used during the pandemic to fast-track approval of medical devices for use in Canada.
West Virginia distributed 50,000 fake DTC3X masks to first responders — and kept them in use after the CDC warned the state they might be counterfeit, and after the real Shanghai Dasheng Co. warned that its products were being faked.
CBC News has asked Health Canada and Public Services and Procurement Canada about the masks, but has not yet received an answer.
Testing reveals quality problems
Canada was badly burned once already when it bought millions of defective masks from a Montreal-based supplier that uses Chinese manufacturers.
The U.S. government had to withdraw dozens of approvals for Chinese manufacturers of medical masks last week after tests showed that many did not meet minimum standards for protecting medical worker