Abbott blood glucose test recall receives Class I notice from FDA
This article was originally published in Clinica
Executive Summary
The US FDA has given Abbott’s recall of 359 million blood glucose test strips a Class I designation – the most severe category that a medical device recall can receive. Abbott discovered that the test strips may give false low blood glucose results and could potentially cause patients or health care providers to raise their blood glucose unnecessarily. This action could result in serious health consequences, including death. The recall, which was issued in December, covers the firm’s Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn and Ultima test strips. The affected tests were manufactured between January and September 2010. Abbott has requested customers to discontinue use of the test strips and return the products.