Roche unit recalls Accu-Check insulin pumps
This article was originally published in The Gray Sheet
Executive Summary
Switzerland-based Roche subsidiary Disetronic Medical Systems recalls certain batches of its Accu-Check Spirit insulin pumps because the "up" or "down" buttons that are used to change programmed settings or to administer additional insulin may fail to function, the firm announced April 30. Customers can contact the Accu-Check Spirit hotline for a replacement pump, which should arrive in 1-2 business days. The defect was detected during normal quality control monitoring, the firm says
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.