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: Class I Recall
MedSun: Newsletter #59, April 2011

FDA MedWatch Safety Alert

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. 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.

Additional Information:

FDA MedWatch Safety Alert. Gen-Probe Inc., AccuProbe Culture Identification Tests: Class I Recall. March 17, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247569.htm


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