FDA slaps its most serious label on Abbott's diabetes recall

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Abbott is recalling some test strips that can lead to inaccurate readings with its FreeStyle and FreeStyle Flash glucose meters.--Courtesy of Abbott

Abbott Laboratories ($ABT) is in the midst of a voluntary recall of some test strips for its blood glucose meters, and now the FDA is warning that use of the faulty products could lead to serious injury or death.

At issue are Abbott's FreeStyle and FreeStyle Lite test strips, which can lead to falsely low blood glucose readings when used with some of the company's older meters. Abbott launched the recall in November, asking customers with affected lots to send them in for replacement, and now the FDA has affixed its most-serious Class I label to the effort, a tag reserved for potentially deadly malfunctions.

An erroneously low glucose reading could spur patients to misdose themselves, the agency said, increasing risks of hyperglycemia, which can be fatal. The FDA is asking patients and physicians to report any adverse events tied to the strips through its online MedWatch platform.

As Abbott has repeatedly noted, the issue only crops up with the FreeStyle and FreeStyle Flash meters, which have been out of production since 2010, and with the OmniPod, which is made by Insulet ($PODD). The strips give correct readings when used with the company's newer FreeStyle Freedom and FreeStyle Lite meters, Abbott said.

The test-strip issue was the second bit of regulatory trouble for Abbott's diabetes device business last year, following a Class I recall of some FreeStyle InsuLinx meters in the spring. Those devices were prone to giving inaccurate readings at extremely high blood glucose levels, the company said.

- read the FDA's note

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