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Luminex, Prodesse, and BD Get FDA Warning Letters for H1N1 Flu Tests

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has sent warning letters to three diagnostics makers — Luminex, BD, and Prodesse — for marketing tests for the 2009 H1N1 Flu Virus, also known as the swine flu, that have not been cleared for marketing by the agency.

The letters were sent to the firms last month and instructed them to "take immediate action to ensure that your firm is not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 Flu Virus that have not been approved, cleared, or authorized by FDA."

The products targeted by FDA include Luminex's xTAG Respiratory Viral Panel, the BD Directigen EZ Flu Test, and Prodesse's ProFlu+ Assay.

The assays are among many devices, herbal extracts, inhalers, masks, and other products that the FDA has placed on a "fraudulent products list" alerting consumers about web sites that are "illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus."

Thus far, FDA has cleared under Emergency Use Authorization only one molecular diagnostic assay for testing for the virus, which is made by the US Centers for Disease Control and Prevention.

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