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November

November 2007 - Urgent Medical Device Alert - Inverness Medical Professional Diagnostics

As the manufacturer of Clearview Mono Cassette (Part No. 92401 All Lots) Inverness Medical Professional Diagnostics has notified your distributor that there are concerns that the product may be being used "off label." Specifically, the package insert includes an age limitation that states "This assay has not been established for patients under 18 years of age

While the product is meeting all of its documented specifications, it is important to note that the product has not been validated for use with pediatric specimens.

Recommended Action:

We request that you don not use any specimens collected from patients under 18 with this test.

If you have any questions regarding this notification, you may contact Technical Service at 800-637-3717.

We apologize for any inconvenience that this may cause.

Martin Sellers
Sr. Director, Regulatory Affairs/Quality Assurance