The swabs in some batches of 1 model of coronavirus home-test kits are “lower than customary”, well being secretary Matt Hancock has mentioned.
As a precaution, the federal government says the kits made by Randox shouldn’t be used till additional discover.
There isn’t any proof of hurt being performed and no impression on entry to testing, Mr Hancock mentioned.
Randox claims to be answerable for as much as 17% of the whole exams carried out within the UK.
The swabs are used to gather a pattern from the again of the throat and nostril, which is then despatched to a lab to check for the virus.
Mr Hancock informed the Commons he was contacted on Wednesday afternoon about the issue.
He mentioned the certification behind the CE security mark on the product was “not forthcoming”.
In an announcement earlier on Thursday, the Division of Well being and Social Care mentioned: “The danger to security is low and check outcomes from Randox kits should not affected.”
It mentioned it might be “supporting all testing settings to obtain substitute kits as quickly as potential”.
Exams kits produced by Randox Laboratories, which have been utilized in care properties and despatched to individuals at residence, are clearly marked with the corporate’s title.
Kits which have already been used can nonetheless be collected for processing as regular.
Baroness Dido Harding, head of NHS Take a look at and Hint in England, which has a separate contract with Randox, mentioned it was too early to touch upon the impression of the protection situation, however she mentioned check outcomes had been “not affected”.