CLIN CHEM ALBUMIN BCG REAGENT

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 CONTACTED ABBOTT TO REPORT THAT THE LAB IS HAVING TROUBLE WITH THE CLINICAL CHEMISTRY ALBUMIN BCG REAGENT, LOT 77056HW00, WHERE SOME OF THE PACKS GENERATED QUALITY CONTROLS THAT FAIL HIGH FOLLOWING CALIBRATION. THE CUSTOMER STATED THAT ONCE THEY RECALIBRATE THE ASSAY, THE CONTROLS ARE IN ACCEPTABLE RANGE. AN ABBOTT REPRESENTATIVE WENT TO THE CUSTOMER FACILITY AND CONFIRMED THE INCORRECT ASSAY CONFIGURATION FOR THE CLINICAL CHEMISTRY ALBUMIN BCG REAGENTS. ADDITIONALLY, THE CUSTOMER WAS UNABLE TO BRING THE ANALYZER INTO "READY" STATUS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

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.