IMMUNOCARD

Description of Event or Problem

WHEN PERFORMING PATIENT TESTING USING IMMUNOCARD TOXIN A& B, THE WASH REAGENT WOULD NOT ABSORB INTO THE REACTION PORTS AND THEREFORE THE TESTING COULD NOT BE COMPLETED. TESTING WAS ATTEMPTED USING A CARD FROM A SECOND BOX WITH THE SAME LOT NUMBER. THE SAME ISSUE OCCURRED. QUALITY CONTROL TESTS USING CARDS FROM THAT LOT PERFORMED SATISFACTORILY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE WASH REAGENT WOULD NOT ABSORB INTO THE REACTION PORTS ON THE TEST CARD.====================== MANUFACTURER RESPONSE FOR IMMUNO TOXIN A&B TEST CARD, IMMUNOCARD======================THE COMPANY SENT 3 REPLACEMENT KITS OVERNIGHT AND ASKED TO HAVE THE DEFECTIVE KITS SENT BACK TO THEM.======================THE REPORTER INDICATED THAT ALL THE BOXES INVOLVED IN THIS EVENT WERE THE SAME LOT NUMBER. THEY "SENT THE PATIENT TESTING TO A REFERENCE LAB FOR COMPLETION." THE NEW KIT HAS DIFFERENT LOT NUMBERS AND WORKED SATISFACTORILY. THERE WAS NO OBSERVABLE MANUFACTURING PROBLEMS AND THE MANUFACTURER DID NOT GIVE THEM AN EXPLANATION AS TO WHY THIS HAPPENED.