CLIN CHEM ALBUMIN BCG REAGENT

Additional Manufacturer Narrative

(B)(4), SUSPECT MEDICAL DEVICE, LOT NUMBER, ADDITIONAL SUSPECT LOT NUMBERS: (B)(4), MANUFACTURE DATE: 7/15/09, EXPIRATION DATE: 7/15/11, (B)(4), MANUFACTURE DATE: 10/15/11, EXPIRATION DATE: 10/15/11. 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 (B)(4). 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 (B)(4).

Description of Event or Problem

ABBOTT CLINICAL CHEMISTRY ALBUMIN BCG REAGENT DEMONSTRATED QUALITY CONTROL RESULTS OUT OF RANGE HIGH FOR LOT 77056HW00. IN ADDITION, PARTICULATE MATTER HAS BEEN OBSERVED IN SOME CLINICAL CHEMISTRY ALBUMIN BCG CARTRIDGES. ABBOTT INTERNAL TESTING WAS PERFORMED USING SEVEN SUSPECT ALBUMIN BCG CARTRIDGES FROM LOT 77056HW00. FOUR CARTRIDGES GENERATED RESULTS OUT OF RANGE HIGH; THREE OF THOSE FOUR CARTRIDGES WERE IDENTIFIED AS CONTAINING PARTICULATE MATTER. A PRODUCT RECALL HAS BEEN ISSUED AND REPORTED UNDER 21CFR806 FOR THE ABBOTT CLINICAL CHEMISTRY ALBUMIN BCG REAGENT, LOTS 77056HW00, 80051PHW00 AND 83030HW00, TO THE FDA (B)(4) ON MARCH 11, 2010. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.

Additional Manufacturer Narrative

(B)(4), SUSPECT MEDICAL DEVICE:CLINICAL CHEMISTRY ALBUMIN BCG REAGENT, ADDITIONAL LOTS: 80051HW00, EXPIRATION 7/15/11;83030HW00, EXPIRATION 10/10/11.CONCOMITANT MEDICAL DEVICE:ARCHITECT C4000 ANALYZER, LIST # 2P24;ARCHITECT C8000 ANALYZER, LIST # 1G06;ARCHITECT C16000 ANALYZER, LIST # 3L77;AEROSET ANALYZER, LIST # 9D05-01.THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.