Abbott Laboratories ($ABT) acknowledged that a number of its glucose test strips may produce bogus low blood-glucose results when used with certain older-model meters, so executives turned to a voluntary recall as a safety precaution.
The recall involves 20 lots of Abbott's FreeStyle and FreeStyle Lite blood glucose test strips shipped for use in the U.S. They're from lots that expire between May 2014 and March 2015, Abbott said in an announcement posted on the FDA's website.
At issue: the presence of both old and new glucose meter technology in the marketplace. If used with Abbott's FreeStyle and FreeStyle Flash blood glucose meters, the test strips could produce "erroneously low blood glucose results," Abbott cautioned in its release. But it also noted that both meters haven't been in production since 2010 (though many are clearly still in use). The company was quick to emphasize that its newer-model FreeStyle Freedom, Lite and Freedom Lite meters have no problems with the glucose test strips in question. Neither does the company's FreeStyle InsuLinx, which uses its own InsuLinx test strips.
Affected customers can contact the company to get their test strips replaced for free, Abbott said.
Abbott's InsuLinx may not be affected by Abbott's latest recall, but the device has had its own share of problems in 2013. Abbott announced in April that it was yanking the FreeStyle InsuLinx blood glucose meters off of the U.S. market because of a risk they'd produce an inaccurate reading at very high blood glucose levels. The FDA has since slapped its most-serious Class I label on the effort because of the risk that the malfunction could seriously injure patients or lead to their deaths.
- read Abbott's announcement