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Recall of Modified Alsever's Solution, Blood Cell Diluent

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    January 25, 2005

LOT NUMBER / Expiration Date

    ALS843-2     9/16/2005


    Gamma Biologicals, Inc
    Houston, Texas


    Gamma has identified microbial contamination in some bottles of Alsever's Solution. The Alsever's Solution may contain white particulate material. Consignees should discontinue use of this product and discard those red cells suspended in Modified Alsever's Solution if there are signs of contamination. Results generated with red cells stored or suspended in this solution are considered valid as long as the red cells did not show signs of contamination at the time of testing. Consignees are also asked to contact the manufacturer to arrange for replacement of any unused bottles of Modified Alsever's Solution.

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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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