Blood glucose test strips sold in these packages have been declared misbranded by FDA and should not be used. (Courtesy FDA)
FDA has announced the recommendation that use of Shasta Technologies' GenStrip Glucose Test Strips be discontinued immediately and remaining stocks be removed from store shelves.
The strips are designed for use with LifeScan Inc.'s OneTouch family of glucose meters (including Ultra, Ultra 2 and Ultra Mini) but were made by Shasta Technologies LLC (Calistoga, CA), a third-party provider. They are available through online retailers and retail pharmacies. LifeScan is a subsidiary of healthcare giant Johnson & Johnson and has no business relationship with Shasta Technologies. According to FDA, the affected test strips have been manufactured and distributed since March 2013.
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Citing "extensive violations" of Quality Systems Regulations (QSRs) and Shasta Technologies' refusal to conduct a voluntary recall, the FDA Safety Communication advises people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. FDA recommends using alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
These violations were detailed in an April 8 Warning Letter FDA sent the company. The Warning Letter lists 11 separate violations. Apparently the company's responses were insufficient to address FDA's concerns in the two-week window allowed for responses before the Safety Communication was issued.
While on the surface this announcement of FDA's recommendation that use of Shasta's GenStrip test strips be discontinued is a simple case of a company not paying sufficient attention to FDA regulations, a little scratching beneath the surface reveals a more complex, and interesting, tale. It seems that after FDA's December inspection, Shasta Technologies sold its GenStrip business lock, stock, and barrel to a company called Pharma Tech Solutions, Inc., which is a subsidiary of Decision Diagnostics Corp. (Westlake Village, CA). Decision Diagnostics announced the deal on April 16, eight days after the date on FDA's Warning Letter but almost two weeks before the Safety Communication.
In November 2013, Decision Diagnostics won a patent infringement action regarding Shasta's GenStrips that had been brought by LifeScan and J&J. They have also been engaged in an antitrust and false advertising countersuit against LifeScan and J&J.
In a February 18 press release describing the progress of their lawsuit, Decision Diagnostics describes itself as "the exclusive worldwide sales, service and regulatory processes agent for the popular Shasta GenStrip ... specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters." So they must have known what was going on at Shasta.
Stephen Levy is a contributor to Qmed and MPMN.
