Kits used to test patients for diseases such as strep and tuberculosis are being recalled because the kits may contain tube components that are partially empty or empty of solution and may give false-negative results. This could cause a delay or lack of treatment, which could be detrimental to one’s health.

The recall involves the Gen-Probe Inc, AccuProbe Group B Streptococcus Culture Identification Test, the Accuprobe Mycobacterium Tuberculosis Complex Culture Identification Test, and the AccuProbe Mycobacterium Avium Complex Culture Identification Test. The Food and Drug Administration (FDA) lists the recall as a Class 1, which is the most serious type of recall the agency can issue and involves cases where there is a strong probability that the products may cause serious injury or death.

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.

Gen-Probe is recommending its customers discontinue using the recalled products, and for customers who have used the recalled products and received negative results, to notify the referring physician about the possibility of a false negative result.

Any side effects related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.