UK Recalls 750,000 Coronavirus Testing Kits

Due to concerns over safety standards and issues up to 750,000 coronavirus unused testing kits have been recalled by UK that were manufactured by Randox.

At the start of the coronavirus crisis, the Department of Health and Social Care (DHSC) is understood to have operated a chaotic policy for procurement of  testing kits and it faced criticism for the purchase of millions of kits that turned out to be significantly less effective than originally claimed by pharmaceutical companies.

The recall ordered by the Medicines and Healthcare products Regulatory Agency (MHRA) comes after the UK government instructed care homes and members of the public to immediately stop using Randox testing kits in mid-July following fears over sterility.

DHSC spokesperson said: “We have high safety standards for all coronavirus tests. Following the pausing of Randox kits on 15 July, Randox have now recalled all test kits as a precautionary measure.”

“Our testing support for care homes continues as any resident or member of staff with symptoms can immediately access a free test and we are exploring ways to increase the amount of testing, making full use of available lab capacity.”

The department has commissioned an accredited laboratory to verify the sterility of a specific supplier of Randox swabs according to the formal international standard for sterility testing. The results of the investigation are expected in the coming weeks.

Randox have recalled all test kits as a precaution to ensure paused kits do not continue to be used while the safety checks are ongoing. The tests are not officially CE marked, assessed before being placed on the market in the European Economic Area, and have not received an exemption to be placed on the market during the pandemic.

DHCS is in the process of contacting every setting which has sent test kits for processing to remind them of the instruction to ensure kits are not used, though the regulatory responsibility to issue a recall lies with Randox. DHSC has also instructed Randox to recall all Randox test kits from NHS test and trace testing settings. It said: “The risk to safety is low and test results from Randox kits are not affected.”

A Randox Laboratories spokesperson said it had not been provided with satisfactory evidence to support the CE marking for Covid-19 sample collection kits purchased from an external supplier. “Noting the lack of CE certification by the supplier and that some kits remain in the field at this time, Randox has, as a regulatory measure, initiated the recall of those kits used within the national testing programme,” they said.

“Randox Laboratories will continue to provide high-volume Covid-19 testing to the national testing programme from their laboratories, based on sample collection kits from other providers.”

 

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Backlash by China and HK officials after US Sanctions

China’s top representative and Hong Kong’s leader took high shots at United States after Trump decided to put sanctions on them and other nine officials for allegedly cracking down on their freedom and undermining the local autonomy of the former British colony.

Chief Executive Carrie Lam took to Facebook to say that the U.S. got her speech wrong, listing the official address of her chief deputy instead. She noted that she was the deputy when she applied for her U.S. visa in 2016. Lam said: “By the way, my entry visa to the U.S. is valid until 2026. Since I have no desire to visit this country, it looks like I can take the initiative to cancel it”.

The sanctions, announced Friday by the U.S. Treasury Department, block all property or other assets that the individuals have within U.S. jurisdiction. Luo Huining, the director of the central government’s liaison office in Hong Kong, said being included on the list shows that he has done what he should for the city and his country. “I don’t have a penny of assets abroad. Isn’t it in vain to impose `sanctions’? Of course, I can also send 100 U.S. dollars to Mr. Trump for freezing,” he said in a statement on the office’s website.

Hong Kong Commerce Secretary Edward Yau, who wasn’t sanctioned, called the sanctions “unreasonable and barbarous” and said they would harm U.S. interests in the city, an Asian financial and shipping hub. Hong Kong has long appreciated civil liberties not seen in mainland China because it is governed under a so-called “one country, two systems” principle in place since it reverted to Chinese rule in 1997.

However, Beijing forced a national security law on Hong Kong at the end of June, following months of anti-government protests last year. The new law forbids what Beijing views as secessionist, subversive or terrorist activities or what it sees as foreign intervention in Hong Kong’s internal affairs. Police now have sweeping powers to conduct searches without warrants and order internet service providers and platforms to remove messages deemed to be in violation of the legislation.

Critics see the law as Beijing’s boldest move yet to erase the divide between Hong Kong’s Western-style system and the mainland’s authoritarian way of governing.

It said that while national security is under the purview of the central government in any country, the new law authorizes local authorities in Hong Kong to be its main enforcer and specifies that human rights will be protected.

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