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DATE NOTIFICATION INITIATED: May 13, 2004 PRODUCT: HIV-1 / HIV-2 Plus O EIA Testing Software MANUFACTURER: DiaSorin, Inc Stillwater, Minnesota REASON: An error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay. The error induced specimen and conjugate incubation temperatures for the assay to remain at ambient temperature rather than the required 37°C temperature. Consignees will receive replacement disks. The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated May 6, 2005

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