The government has confirmed that the NHS Test and Trace service has been informed that some test kits produced by Randox Laboratories “may not meet our safety standards required for coronavirus testing”.
He said replacement kits would be sent “as soon as possible”.
Randum laboratories, based in Crumlin, won the £ 133m contract from the Ministry of Health and Social Affairs (DHSC) in May after a non-competitive bidding process, reports the Mirror.
Health Secretary Matt Hancock told members of the House of Commons, “We have identified test swabs that do not meet the high standards we expect and will be testing further on this lot.
“As a precaution, and while we are investigating further, we request that the use of these Randox swab test kits be suspended in all settings until further notice.
“This problem was brought to my attention yesterday afternoon, we contacted the settings using these swabs last night and immediately posted the break notice.
“The clinical advice is that there is no evidence of harm, the test results are not affected, there is no evidence of problems with our other test pads and there is no impact on access to tests. ”
Hancock said the break only applies to Randox test swabs and none of the other companies involved in the four-country agreement which includes Thermo Fisher Scientific, Amazon, Boots and Royal Mail.
Randox told the Guardian that he had temporarily suspended the distribution of home sample collection kits using a particular batch / supplier of pads, “as an immediate precaution.”
She stated that this did not apply to her private company, which she said uses another supplier.
Asked by Jonathan Ashworth, the fictional secretary of health and social services, about what was wrong with the Randox lot, Mr. Hancock said, “The reason is that they had a CE stamp and after investigating the certification of this stamp, the certification of this stamp was not sent and physical checks were therefore carried out and we found that the swabs did not meet the standards we expected. ”
He added, “There is no evidence of harm. ”
CE marking is required for many products and this shows that the manufacturer has verified that these products meet EU safety, health or environmental requirements.
Randox’s website states: “Our innovative test for COVID-19 uses patented Randox biochip technology to accurately and reliably diagnose COVID-19, thereby facilitating proper containment and reducing the spread of disease.
“The biochip includes two tests for COVID-19; a specific and a confirmatory as recommended by WHO. ”
The update said that Randox is responsible for 17% of the total testing done by the government’s national Covid-19 testing program.