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FDA Issues Strong Safety Warning Against Shasta GenStrip

On April 29, the FDA issued a strongly-worded safety communication that advised patients and health care providers to stop using the GenStrip from Shasta Technologies, a third party “generic” strip that can be used with LifeScan’s OneTouch Ultra, Ultra 2, and UltraMini meters (i.e., the strip is not made by LifeScan, but works with LifeScan meters). The FDA also informed retailers to stop selling and distributing the product, as well as to remove unsold strips from shelves. The Agency believes that the GenStrip may report inaccurate blood glucose readings, a view that stems from a revealing inspection of Shasta Technologies’ facility – notably, the FDA found 11 (!) violations in quality systems. Disappointingly, Shasta refused to voluntarily recall its strips.

Around the same time of the FDA announcement, Decision Diagnostics acquired Shasta’s GenStrip technology. Notably, Decision plans to continue selling the GenStrip, a move that we assume will be further investigated by the FDA. Although it’s difficult to predict what will happen next, this certainly isn’t the end of the story. Indeed, UniStrip1, a new FDA-approved generic strip for LifeScan meters, was launched on April 9. There’s no question that third party generic strips do offer a cost advantage relative to their branded counterparts, but these companies’ quality systems and commitment to patient safety are a major unknown. –NL