A Northwell Well being lab technician makes use of the Abbott ID NOW COVID-19 fast tester on a participant earlier than a information convention, at a pop up COVID-19 vaccination sight at Belmont Park in Elmont, New York, U.S., April 14, 2021. Mary Altaffer/Pool by way of REUTERS/File Picture
Oct 14 (Reuters) – A unit of Abbott Laboratories (ABT.N) is recalling two COVID-19 check kits as they will probably challenge false constructive outcomes, the U.S. Meals and Drug Administration (FDA) stated on Thursday.
The regulator has recognized the recall of the Alinity m SARS-CoV-2 AMP and the Alinity m Resp-4-Plex AMP laboratory check kits by unit Abbott Molecular Inc as a Class 1 recall, essentially the most critical sort.
The company in September issued a letter cautioning healthcare suppliers and scientific laboratories of a possible for false constructive outcomes with the 2 exams, and really useful they contemplate retesting constructive affected person samples with one other approved COVID-19 check.
An overflow of 1 affected person pattern into one other whereas mixing chemical substances with the samples could possibly be associated to the false constructive outcomes, the FDA stated on Thursday.
The company stated no deaths or opposed well being penalties have been reported from use of the exams.
Abbott has a variety of FDA-authorized COVID-19 exams, together with antigen, molecular and serology, which helped enhance its income throughout the peak of the pandemic final 12 months.
Reporting by Amruta Khandekar; Modifying by Devika Syamnath
Our Requirements: The Thomson Reuters Trust Principles.
0 Comments