CLIN CHEM ALBUMIN BCG REAGENT

Description of Event or Problem

THE CUSTOMER OBSERVED A LARGE REAGENT TO REAGENT VARIATION FOR CLINICAL CHEMISTRY ALBUMIN BCG LOT 77056HW00. THE CUSTOMER DETECTED SOME COLOR VARIATION AND PARTICULATE RESULTING IN ERRATIC RESULTS, REQUIRING THE CUSTOMER TO RECALIBRATE EVERY REAGENT PACK. THE CUSTOMER OBSERVED AN INCREASE IN INTERNAL QUALITY CONTROLS OUTSIDE THE ACCEPTABLE RANGE WHEN USING MULTIPLE REAGENT PACKS, CALIBRATORS AND CALIBRATIONS. THE CUSTOMER CHANGED TO A NEW REAGENT LOT AND OBSERVED A LARGE SHIFT DOWN IN QUALITY CONTROLS AND BETTER ACCURACY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

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.

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.