CLIN CHEM ALBUMIN BCG REAGENT

Description of Event or Problem

THE CUSTOMER OBSERVED SHIFTS IN THE CLINICAL CHEMISTRY ALBUMIN BCG QUALITY CONTROL (QC) RESULTS FOR THE HIGH AND LOW QC SAMPLES WHEN A NEW BOTTLE OF REAGENT LOT 80051HW00 WAS PUT ON THE ANALYZER. THE CUSTOMER NOTICED TWO BOTTLES OF THE SAME REAGENT LOT GAVE MARKEDLY DIFFERENT QC RESULTS THAN PREVIOUSLY GENERATED. RECALIBRATION BROUGHT RESULTS BACK INTO THE QC MEAN, HOWEVER, WHEN A NEW BOTTLE OF REAGENT WAS PUT ON THE ANALYZER, THE QC VALUES DROPPED FOR BOTH THE LOW AND HIGH CONTROLS. THE CUSTOMER STATED REPEATED RECALIBRATION CORRECTED THIS ISSUE. THE CUSTOMER CONFIRMED THIS ISSUE BY USING THE SAME REAGENT TO ANOTHER ANALYZER IN THE LAB WHICH HAD BEEN FULLY CHECKED BY ABBOTT FIELD SERVICE. THE CUSTOMER NOTED ALL OTHER ASSAYS ARE WORKING AS THEY SHOULD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

(B)(4). ARCHITECT C8000 ANALZYER, LIST # 1G06-01, (B)(4). THE CAUSE OF THE PARTICULATE MATTER (PENICILLIUM SP, A FUNGAL SPECIES FOUND IN THE ENVIRONMENT) OBSERVED IN SOME CLINICAL CHEMISTRY ALBUMIN BCG REAGENT CARTRIDGES WAS DUE TO EXPOSURE OF THE ALBUMIN BCG FORMULA CONTAINING WEAK ANTIMICROBIAL ADDITIVE FROM NORMAL FORMULATION AND FILTERING PROCESSES DESIGNED FOR MICROBIAL GROWTH CONTROLLED CLINICAL CHEMISTRY REAGENTS. ABBOTT ISSUED A PRODUCT RECALL ADVISING CUSTOMERS TO DISCARD OR DESTROY ANY INVENTORY OF THREE AFFECTED LOTS OF CLINICAL CHEMISTRY ALBUMIN BCG REAGENTS. ABBOTT IS IDENTIFYING ALTERNATE FORMULATION FOR THE CLINICAL CHEMISTRY ALBUMIN REAGENTS THAT CONTAIN NO MERCURY.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C8000 ANALYZER, LIST # 1G06-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.