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Market Withdrawal of HIV-1 / HCV Assay, Procleix

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DATE WITHDRAWAL INITIATED:

    January 18, 2005

PRODUCT / LOT NUMBERS:

    HIV-1 / HCV Assay, Procleix

    Lot Number: 401254

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

MANUFACTURER:

    Gen-Probe Inc
    San Diego, CA

DISTRIBUTOR:

    Chiron Corp
    Emeryville, CA

REASON:

    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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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.

 

 
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