A list of field safety notices (“FSNs”) from medical device manufacturers is maintained by the Medicines and Healthcare products Regulatory Agency (“MHRA”). In a previous article we attached a list of 24 FSNs relating to “SARS” devices between 1 January and 30 November 2021 – 15 of them relate specifically to PCR Tests and at least one relates to a lateral flow antigen test, two of these were issued by DnaNudge.
DnaNudge has a creepy sales pitch: “Here at DnaNudge, we’ve pioneered something completely new – the ability to nudge your everyday shopping choices through your DNA,” their online shop says. It is a company that was formed in 2015 and founded by Chris Toumazou, Regius Professor of Engineering Imperial College London, and Dr. Maria Karvela. DnaNudge’s two recently appointed directors are: Sir Richard Sykes, chair of the UK’s Vaccine Taskforce who was appointed as director of DnaNudge in December 2021; and, Mohammed (“Mo”) El Husseiny, founder of Ventura Capital.
Their ‘lab in a cartridge’ device was approved for clinical use by the MHRA at the end of April 2020 and in August 2020, the UK government purchased 5.8m DnaNudge Covid tests, at a cost of £161m or just under £28 each, to be rolled out in patient care and elective surgery settings.
A couple of months later, in October, DnaNudge entered into a deal with manufacturer Jabil Healthcare to produce 1.4 million “CovidNudge” test cartridges per month by early 2021. A move to expand their customer base is motivated by money. The units are being sold to NHS hospitals at cost price, Prof. Toumazou said, “We’ve sold it at cost to the NHS as a philanthropic thing, but our consumer business [on other products] is suffering because we haven’t put the resources into that.”
Formerly Nypro, Jabil Healthcare’s website states that it serves five key sectors in the healthcare market: medical devices, orthopedics; diagnostics; pharmaceutical delivery systems; and, consumer health. Adding that “taking centre stage are Internet of Things (IoT) and digital health platform innovations enabled by connectivity, sensors and miniaturisation.”
In early November 2020 DnaNudge announced their Covid test was available for people without Covid-19 symptoms. The test is able to return results in 90-minutes and up to 10 people in a work, friends, family or other close contact “bubble” can be tested at the same time on the same cartridge, at a cost of £10 per person.
On 22 December 2020, DnaNudge issued its first FSN which affected all batches. DnaNudge’s customers had complained there was a disconnection between the blue top cover and the clear bottom cover of the “DNACartridge.” “If any cartridges are identified with loose or missing lids, DO NOT attempt to replace the lid, please dispose of the item appropriately and continue testing with a new cartridge,” DnaNudge instructed....<<<Read More>>>....
