AUDIENCE: Laboratory, Infectious Disease, Health Professional
ISSUE: 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.
BACKGROUND: 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.
RECOMMENDATION: Gen-Probe is recommending that customers discontinue using the identified batch (lot) numbers. For customers who used these batches and obtained negative results, the firm recommends that the referring physician be notified about the possibility of a false negative result.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[03/17/2011 - Recall Notice - FDA]