Update on Sample Kits
STATEMENT FROM RANDOX: 07 August 2020
Randox Laboratories have today taken the decision to recall Covid-19 sample collection kits, following the identification of incomplete EC certification. On 15th July DHSC placed these kits on hold due to the absence of swab certification from an external supplier. 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 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.
DHSC have stated the risk to safety is low and test results from Randox kits are not affected.
This recall applies only to sample collection kits within the UK National Test and Trace Programme. Randox private customers or kits are not affected.
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