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Vaccines, Blood & Biologics

Market Withdrawal of HIV-1 / HCV Assay-Procleix - Gen-Probe Inc



January 18, 2005



HIV-1 / HCV Assay, Procleix


Lot Number: 401254


1000 Test Kit - Part Number 301031
5000 Test Kit - Part Number 301030




Gen-Probe Inc
San Diego, CA


Chiron Corp
Emeryville, CA


Procleix HIV-1 / HCV Assay, Master Lot 401254, was found to contain an elevated level of copper. The source of the elevated copper was the raw material, Trehalose, which is also a component of the Enzyme Reagent. The increase in copper may affect kit performance.


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Food and Drug Administration

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Silver Spring, MD 20993-0002

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