CLIN CHEM ALBUMIN BCG REAGENT

Additional Manufacturer Narrative

(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 OBSERVED CLINICAL CHEMISTRY ALBUMIN BCG CONTROLS OUT OF RANGE WHEN REVIEWING THE NIGHT SHIFT'S QUALITY CONTROL DATA. THE CUSTOMER DETERMINED PATIENT RESULTS WERE REPORTED OUT OF THE LAB WHEN THE ALBUMIN CONTROLS WERE OUT OF RANGE. THE CUSTOMER SENT CALIBRATION DATA, (B)(4) DATA AND PATIENT DATA TO ABBOTT FOR EVALUATION. THE CUSTOMER SUCCESSFULLY RECALIBRATED THE ALBUMIN ASSAY WITH THE QUALITY CONTROLS WITHIN SPECIFICATION AND RE-ASSAYED PATIENT SAMPLES FROM THE RUN WITH CONTROLS OUT OF RANGE. AN EXAMPLE OF THE PATIENT DATA IS AS FOLLOWS: INITIAL RESULT: 3.2 G/DL, REPEAT RESULT: 4.0 G/DL THE INITIAL PATIENT RESULT AND A CORRECTED PATIENT RESULT WAS REPORTED OUT OF THE LAB, HOWEVER, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.