ARCHITECT C-PEPTIDE REAGENT

Description of Event or Problem

THE CUSTOMER OBSERVED A SHIFT HIGH IN BIORAD QUALITY CONTROLS WHEN CLINICAL CHEMISTRY C-PEPTIDE REAGENT LOT 01711A000 WAS IN USE. THE CUSTOMER STATED CLINICIANS QUESTIONED MULTIPLE PATIENT RESULTS, HOWEVER, AFTER REPEATED REQUESTS BY ABBOTT, THE CUSTOMER DID NOT PROVIDE ANY EXAMPLES OF THIS DATA FOR REVIEW. FALSELY ELEVATED RESULTS WERE REPORTED OUT OF THE LAB, HOWEVER, THERE WAS NO KNOWN IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

(B)(4). THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROLS AND PATIENT RESULTS WAS DUE TO A NEW ANTIBODY LOT USED IN THE MANUFACTURING OF THE C-PEPTIDE MICROPARTICLE AND/OR CONJUGATE REAGENTS. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCARD AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.