AccuProbe Test Kits Recalled

Washington, DC: A Class 1 Recall has been issued for Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test.

The affected kits may contain tube components that are partially empty or empty of solution. Possible false-negative results may occur. This may cause serious adverse consequences and/or death. See the Recall Notice for specific lot numbers affected.

These products were manufactured from September 24, 2008 through October 31, 2008 and distributed from October, 2008 through December, 2008.

AccuProbe Group B Streptococcus Culture Identification Test is primarily used to screen pregnant women for bacteria called group B streptococcus (group B strep). Group B strep causes life-threatening infections in pregnant women, newborns, the elderly, and adults with other illnesses. Pregnant women who test positive for group B strep at 35 to 37 weeks and who are carriers (as identified by the U.S. Centers for Disease Control and Prevention), are given an antibiotic during delivery to prevent group B strep from being transferred to their newborn during vaginal birth. This test may also be used in conjunction with gynecologic surgery (procedures performed through the vagina rather than through the abdomen).

AccuProbe Mycobacterium Avium Complex Identification Test is used to identify Mycobacterium Avium Complex. People who are infected with Mycobacterium Avium Complex usually have immunocompromising diseases such as Acquired Immunodeficiency Syndrome (AIDS).

AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test is used to identify people who have tuberculosis.

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Published on Mar-17-11