CLIN CHEM ALBUMIN BCG REAGENT

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C16000 ANALYZER, LIST # 3L77-01, (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative

(B)(4). ARCHITECT C16000 ANALYZER, LIST# 3L77-01, (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.

Description of Event or Problem

THE CUSTOMER STATED THEY WERE UNABLE TO GET CORRECT RESULTS ON EITHER ARCHITECT ANALYZER IN THEIR LAB FOR THE CLINICAL CHEMISTRY ALBUMIN BCG ASSAY WHEN LOT 77056HW00 WAS IN USE. THE CUSTOMER STATED WHEN THEY ATTEMPT TO USE THE REAGENT, THE ASSAY WAS CALIBRATED, HOWEVER, CONTROLS WENT OUT OF RANGE. ABBOTT CUSTOMER SERVICE DETERMINED THE CORRECT ASSAY PROTOCOL AND CALIBRATOR VALUES WERE CORRECT, THEREFORE, THE CUSTOMER WAS SENT A REPLACEMENT REAGENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.