CLIN CHEM ALBUMIN BCG REAGENT

Additional Manufacturer Narrative

(B)(4): ARCHITECT ANALYZER, LIST # 1G06-11, SERIAL # (B)(4). THE CAUSE OF THE PARTICULATE MATTER ((B)(6), 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 C8000 ANALYZER, LIST # 1G06-11, (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 ELEVATED CLINICAL CHEMISTRY ALBUMIN BCG CONTROL VALUES AND PATIENT RESULTS THAT WERE GENERATED FROM THE ARCHITECT C8000 ANALYZER WHEN REAGENT LOT 80051HW00 WAS IN USE. THE CUSTOMER STATED THE ALBUMIN RESULTS VARIED WHEN NEW ALBUMIN REAGENT OF THE SAME LOT NUMBER WAS PUT INTO SERVICE. THE CUSTOMER RECALIBRATED THE ALBUMIN ASSAY AND RE-ASSAYED THE PATIENT SAMPLES. THE CUSTOMER PROVIDED AN EXAMPLE OF THE ELEVATED PATIENT RESULTS BEFORE AND AFTER THE ALBUMIN ASSAY RECALIBRATION. INITIAL RESULT: 3.5 G/DL, REPEAT RESULT: 1.9 G/DL. THE CUSTOMER REPORTED THE SUSPECT PATIENT RESULT OUT OF THE LAB, HOWEVER, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.