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April 23rd, 2008

Nanosphere Recalls ‘Very Small Number’ of Verigene Assays Due to ‘Aberrant Result’

Abstract:
Nanosphere in February recalled an unspecified number of its Verigene warfarin metabolism assay cartridges due to faulty results, nearly five months after the US Food and Drug Administration approved the tests, the company disclosed earlier this month.

The recall of the assay, which was the first FDA-approved genetic test of its kind, involved a "very small number of warfarin assay cartridges that Nanosphere wanted to recover to test for the possibility of reproducing an uncharacteristic result," a company spokesperson told Pharmacogenomics Reporter this week.

In an announcement earlier this month, the FDA said that Nanosphere informed the agency of the recall in letters dated Feb. 25. According to the announcement, Nanosphere recalled eight lots of its warfarin metabolism nucleic acid-test cartridge (part number 20-006-002). The FDA designated this a Class II recall, which means that "there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems."

Source:
pgxreporter.com

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