ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT

Description of Event or Problem

THE DEVICE IS A GROUP B (B) (6) TEST THAT IS PRIMARILY USED FOR THE DETECTION OF GROUP B (B) (6) AT 36-38 WEEKS OF PREGNANCY. A MATERNAL SPECIMEN WAS TESTED IN (B) (6) 2008 WITH THIS DEVICE FROM A BATCH THAT WAS SUBSEQUENTLY RECALLED. THE TEST WAS NEGATIVE FOR GROUP B (B) (6). THE MOTHER DELIVERED ON (B) (6) 2009, THE CHILD PRESENTED AT AN EMERGENCY ROOM ON (B) (6) 2009, AND THE CHILD DIED FROM MASSIVE GROUP B STREP INFECTION ON (B) (6) 2009.

Additional Manufacturer Narrative

THE KIT LOT NUMBER (555368) OF THIS DEVICE WAS SUBJECT TO A RECALL DUE TO KITS POTENTIALLY CONTAINING EMPTY, OR PARTIALLY EMPTY, TUBES LABELED AS CONTAINING PROBE REAGENT. IF AN EMPTY OR PARTIALLY EMPTY TUBE IS USED FOR THE POSITIVE CONTROL, THIS COULD RESULT IN A DELAY IN CORRECTLY IDENTIFYING THE ISOLATE DUE TO AN INVALID TEST RUN. ALTERNATIVELY, IF A FILLED PROBE TUBE IS USED FOR THE POSITIVE CONTROL WHILE AN EMPTY OR PARTIALLY EMPTY PROBE TUBE IS USED FOR THE PATIENT TESTING, THIS COULD RESULT IN A FALSE NEGATIVE RESULT. ALL REAGENTS IN THE KIT WERE LABELED CORRECTLY. IT IS ESTIMATED THAT BETWEEN 1% AND 5% OF THE TUBES WERE DEFECTIVE IN THE IMPACTED LOTS. THERE ARE MULTIPLE POTENTIAL REASONS/CAUSES FOR THE INFANT CONTRACTING GROUP B (B) (6) IN (B) (6) 2009, ALTHOUGH, THE MATERNAL SPECIMEN TESTED NEGATIVE IN (B) (6) 2008. THE IVD TEST KIT (THE DEVICE) WAS USED UP AT THE TIME OF TESTING AND IS NOT AVAILABLE FOR FURTHER EVALUATION OR CONFIRMATION.