Bayer's Hong Kong recall of its Contour diabetes testing strips makes its way to the U.S., Bayer releases an official statement.
Updated: 8/17/2011 11:30 p.m.
Bayer HealthCare confirmed that it has recalled all retail stock of its Contour 10- and 25-count and Counter TS 10-count diabetes test strips over a "packaging issue" that resulted in inaccurate glucose readings in some of its products.
Bayer's voluntary recall in the U.S. joins government-recall of all Contour glucose testing strips in Hong Kong. *
During routine quality testing, Bayer found that strips from half of its bottles of low-count strips produced false readings, the Centre for Health Protection of the Hong Kong Dept. of Health reported.
"In-house investigation findings so far point to interaction of the strips with the gas trapped inside the bottles as the cause of the defect," according to the CHP report.
"These actions are not taken as a result of any adverse events reported to Bayer," according to a Bayer press release. "Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing."
The company initiated a voluntary U.S. recall of the affected products from distribution channels and offices of health care providers, Bayer spokesperson Susan Yarin told MassDevice.
No new shipments of the affected tests have been shipped to the U.S. since June, and Bayer expects the remaining quantities in the market to be "really small," according to Yarin.
Pulmonx taps former Asthmatx CEO Glen French to be its new chief executive.
Here's a look at some of the top legal news stories for medical device companies this week: InSightec...
The U.S. says it hammered out a deal with China to speed American-made medical devices and drugs to...
Delcath Systems adds 2 German research centers to a Phase II clinical trial of its Chemosat...
The FDA awards priority review status to Cohera Medical's surgical sealant Sylys because the product...