FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Recall of Modified Alsever's Solution, Blood Cell Diluent

horizontal rule

DATE RECALL INITIATED:

    January 25, 2005

LOT NUMBER / Expiration Date

    ALS843-2     9/16/2005

MANUFACTURER:

    Gamma Biologicals, Inc
    Houston, Texas

REASON:

    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.

horizontal rule

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.

 

 
horizontal rule