VITEK 2 SUSCEPTIBILITY CARD, AST-N045

Description of Event or Problem

A SMALL PERCENTAGE OF CARDS FROM VITEK 2 AST-N045 LOT 167394240 WERE ERRONEOUSLY BAR CODED WHICH WILL CAUSE THE VITEK 2 SYSTEM TO READ AND REPORT THESE CARDS AS VITEK 2 AST-N021 CARDS INSTEAD OF AST-N045 CARDS. THE INSTRUMENT SCREEN AND LAB REPORT WILL SHOW THAT THE CARDS READ AS AST-N021 SO CUSTOMER MAY BE AWARE. AS A RESULT OF THE DIFFERENT CONFIGURATIONS, AND CONTENTS FOR THE TWO VITEK 2 CARD TYPES THE FOLLOWING ANTIBIOTICS/TESTS WILL BE ERRONEOUSLY ANALYZED, AND POTENTIALLY REPORTED IF AN AST-N045 CARD IS READ AS AN AST-N021 CARD: AMIKACIN, AMOXICILLIN/CLAVULANIC ACID, AMPICILLILN, CEFOTAXIME, CEFOXITIN, ESBL, FOSFOMYCIN, GENTAMICIN, MEROPENEM, NITROFURANTOIN, NORFLOXACIN, AND TEMOCOLLIN. THIS MAY CAUSE FALSE SUSCEPTIBLE AND/OR FALSE RESISTANT RESULTS TO BE REPORTED IF THE ERROR IS NOT CAUGHT WHEN THE LAB REVIEWS THE RESULTS. AST-N045 IS A COUNTRY WHEN THE LAB REVIEWS THE RESULTS. AST-N045 IS A COUNTRY CUSTOM SUSCEPTIBILITY CARD MARKETED ONLY IN ANOTHER COUNTRY.

Additional Manufacturer Narrative

ANOTHER COUNTRY, WAS INSTRUCTED TO STOP SHIPMENT. CUSTOMER LETTER WILL BE SENT TO CUSTOMERS INFORMING THEM OF ISSUE. THIS PRODUCT IS SOLD ONLY IN ANOTHER COUNTRY.