CLIN CHEM ALBUMIN BCG REAGENT

Additional Manufacturer Narrative

(B)(4). ARCHITECT C4000 INTGR ANALYZER, LIST # 2P24-01, (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 DEVICE: ARCHITECT C4000 INTGR. ANALYZER, LIST # 2P24-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED ALBUMIN BCG BIORAD CONTROLS ELEVATED BY TWO STANDARD DEVIATIONS WHEN ASSAYED ON THE ARCHITECT C4000 ANALYZER. ALTHOUGH THE CUSTOMER ATTEMPTED RECALIBRATION OF THE ALBUMIN ASSAY, THE CONTROLS WERE STILL HIGH. THE CUSTOMER STATED THE ASSAY HAD BEEN STABLE TO THIS POINT AND ONLY ONE BOX OF REAGENT HAS BEEN USED WITH FIVE WEDGES REMAINING. THE CUSTOMER ALSO STATED THE ALBUMIN MASTER CALIBRATORS AND BIORAD CONTROLS WERE FRESH. THE CUSTOMER WAS ASKED TO RECALIBRATE THE ASSAY TO ALLOW FOR AUTOMATIC CALIBRATION BY THE ALBUMIN BCG KIT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.