Up to 750,000 COVID-19 test kits manufactured by Randox Laboratories have been recalled in the UK. Randox Laboratories, a Northern Ireland-based medical technology company, has been informed to recall the tests as a precautionary measure.
The kits have been recalled over concerns that they do not meet the required safety standards and the company has been instructed by the British government to stop distributing and using the COVID-19 test kits as of July 15.
“The Medicines and Healthcare products Regulatory Agency has instructed Randox to recall all Randox test kits from NHS Test and Trace testing settings,” the ministry of health said in a statement on Friday.
Matt Hancock, Health Secretary, said the swabs in some kits were not up to standard.
According to the BBC, a spokesperson from Randox 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.”
The UK were set to resume care homes visits but there is a delay due to the lack of COVID-19 testing for staff and residents.
About 1.3 million tests have been sent out in the UK. Additionally, there are around 200,000 tests being provided across the UK every day.
A spokesperson for Randox said that the problems arose from the kits having incomplete safety certification, which was not provided by its external supplier of swabs.
Randox International redirected Xtalks to a statement where the spokesperson for Randox said, “to date, Randox have not been provided with evidence to satisfactorily support the CE marking for these swabs. So, 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.”
Randox said they will use other manufacturer’s sample collection kits to “continue to provide high volume COVID-19 testing to the National Testing Programme from their laboratories.” The recall only applies to sample collection kits within the UK National Test and Trace Programme and the kits provided privately are not affected.
COVID-19 Home Testing Kits in North America
In the US, the first at-home COVID-19 testing kits were available starting in April for frontline workers in an attempt to expand testing options in many states. LabCorp was amongst the first to screen people with an online questionnaire, and if approved by a physician, they would send a testing kit to a patient’s home.
The tests are then conducted and sent back to LabCorp in a box and insulated pouch to be reviewed.
Stephan Hahn, Commissioner of Food and Drugs at the FDA, said that the self-swab test is authorized based on data that shows that it is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.
In Canada, home testing kits are not available as they are not approved by Health Canada.
On the Health Canada site, the regulator explains this decision by saying, “without the guidance of a healthcare professional, there is a significant risk that a patient could use the home test kit improperly or misinterpret the results. It may also be impossible for healthcare agencies to collect home test results. This information is key to important public health decisions involving disease control during a pandemic.”
In April, an Ottawa-based company, Spartan Bioscience, had a COVID-19 test approved by Health Canada. However, this test was voluntarily recalled just one month later after the government expressed concerns about its effectiveness. The company recalled 5,500 tests that were shipped nationally.