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FDA Warned Millipore on H1N1 Test Marketing

By a GenomeWeb staff reporter

This article has been updated to include comments from a Millipore spokesperson.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration disclosed on its website Tuesday that it had sent a warning letter to Millipore in September regarding the firm's promotional materials for influenza diagnostics products.

Specifically, the agency cited a promotional e-mail for Millipore's Light Diagnostics brand of respiratory screens and panels and its SimulFluor Flu A/B typing kit. The letter is dated Sep. 29, 2009, but didn't appear on the agency's website until today.

"The FDA has determined that your firm offers products for sale that are intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus in people," the FDA said in the letter. "These products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus."

The FDA requested that Millipore immediately cease marketing any unapproved or uncleared products for the H1N1flu virus.

"We have implemented a number of corrective actions to ensure this does not happen again in the future, and we reached out to everyone who received the promotional e-mail to retract the claim," a Millipore spokesperson told GenomeWeb Daily News via e-mail. "We sent a letter to the FDA in mid-January detailing these actions and we have spoken to the agency."

The FDA has yet to grant 510(k) marketing clearance for any diagnostic test for the 2009 H1N1 Influenza A virus. However, several firms have received Emergency Use Authorization from the agency. The list of those EUAs can be found here.

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