THE ARCHITECT C-PEPTIDE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE ASSAY FOR THE QUANTITATIVE DETERMINATION OF C-PEPTIDE IN HUMAN SERUM, PLASMA AND URINE AND IS USED AS AN AID IN THE DIAGNOSIS AND TREATMENT OF PATIENTS WITH ABNORMAL INSULIN SECRETION INCLUDING DIABETES MELLITUS. DURING A COMPLAINT INVESTIGATION, A PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT C-PEPTIDE REAGENTS, LIST # 3L53-25, LOTS 03610K000 AND 01711A000, WHICH HAVE THE POTENTIAL TO GENERATE FALSELY ELEVATED RESULTS WITH CERTAIN PATIENT SAMPLES AND NON-ABBOTT QUALITY CONTROLS. ABBOTT CONTROLS DO NOT EXHIBIT THIS SHIFT. A PRODUCT RECALL WAS ISSUED AND REPORTED UNDER 21CFR806 FOR THE ARCHITECT C-PEPTIDE REAGENT TO THE (B)(4) DISTRICT ON (B)(4) 2011. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.
N
Patient 1
SUSPECT MEDICAL DEVICE, LOT #: ADDITIONAL SUSPECT LOTS: 01711A000, MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 12/12/11, (B)(4), MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 10/29/11, (B)(4), MANUFACTURE DATE: (B)(4) 11, EXPIRATION DATE: 1/10/12, (B)(4), MANUFACTURE DATE: (B)(4) 2011, EXPIRATION DATE: 4/16/12. PATIENT: NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4); (B)(4). DEVICE: HIGH TEST RESULTS (B)(4); (B)(4) THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROL 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.