FDA Device

The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

Hazard

The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.

What You Should Do

Remedy

Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.

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Products

The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
Brand
Diamedix Corporation
UPC
Lot # 91803Z and 30804/30804Z

Units Affected

178

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