Abbott Faces Serious Recall of Diabetes Products

FDA has recently given Class I status to a recall of Abbott Laboratories' FreeStyle and FreeStyle Lite test strips, which indicates that the products could cause serious injury or death.


Abbott voluntarily recalled the strips because they were found to provide inaccurate readings of blood glucose when used with the FreeStyle and FreeStyle Flash meters and the Insulet OmniPod. The FreeStyle and FreeStyle Flash devices have not been produced since 2010.

Freestyle test strips

In a press release, Abbot explained that the problem in question did not occur with its newer FreeStyle Freedom, Lite and Freedom Lite meters. However, by possibly producing inaccurately low test results for blood glucose levels, the FreeStyle and FreeStyle Lite test strips could raise a diabetics' risk of hypoglycemia, which can lead to unconsciousness, seizures, or death in severe cases.

Abbott announced the recall of 20 lots of the two FreeStyle-branded test strip lines on 27 November 2013.

The company also had an earlier Class I recall of its FreeStyle InsuLinx meters in the spring, which were found to work incorrectly with abnormally high blood glucose levels.


Source: Qmed



qr code

About The Operating Theatre Journal

The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

More »
Follow & Share

Follow The Operating Theatre Journal on Facebook Follow The Operating Theatre Journal on Twitter Follow The Operating Theatre Journal on LinkedIn Follow The Operating Theatre Journal RSS Feed

Help & Support

Problems with, or comments about, this website may be emailed to:

Get in touch

Telephone: +44 (0)2921 680068
Skype: Lawrand Ltd
Email: admin@lawrand.com