IMMAGE C-REACTIVE PROTEIN REAGENT

Additional Manufacturer Narrative

ADDITIONAL LOT #S: M709279 AND M709319. ADD'L EXPIRATION DATES: 10/31/2009 AND 11/30/2009. ADD'L MFR DATES: 10/29/2007 AND 11/15/2007. BCI RECENTLY VALIDATED A SWITCH FROM MERCK LATEX TO SERADYN LATEX. TO CONFIRM THE FINDING, 2 MERCK LATEX CRP LOTS AND ALL 4 SERADYN LATEX CRP LOTS WERE USED TO ASSAY SAMPLES THAT GRADUALLY RANGED UPWARD FROM 35 TO 65 MG/DL. THE 4 SERADYN LOTS BEGIN TO HOOK DOWN TO APPROX 3-7 MG/DL SOMEWHERE BETWEEN 36-65MG/DL. BOTH MERCK LOTS RECOVERED CORRECT VALUES FOR ALL SAMPLES UP THROUGH 65 MG/DL. IN ADDITION, IT WAS NOTED THAT CRP REAGENT WITH SERADYN LATEX LOT NUMBER 1450 HOOKS AT A MUCH LOWER LEVEL THAN DOES CRP REAGENT WITH SERADYN LATEX LOT NUMBER 112161. CRP REAGENT IS INTENDED FOR THE QUANTITATIVE DETERMINATION OF CRP IN HUMAN SERUM OR PLASMA BY RATE NEPHELOMETRY AND THE MEASUREMENT AIDS IN EVALUATION OF STRESS, TRAUMA, INFECTION, INFLAMMATION, AND SURGERY. A CAPA HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THE ISSUE. BCI WILL INITIATE A PRODUCT CORRECTIVE ACTION (PCA) REGARDING THIS ISSUE.

Description of Event or Problem

DURING AN INTERNAL STUDY AT BECKMAN COULTER INC. (BCI) MANUFACTURING CENTER IN CARLSBAD, IT WAS DISCOVERED THAT IMAGE C-REACTIVE PROTEIN (CRP) REAGENT LOTS MADE WITH SERADYN LATEX EXHIBIT A HOOK EFFECT. FURTHER INVESTIGATION REVEALED THAT 4 CRP REAGENT LOTS ARE AFFECTED (3 RELEASED AND 1 IN-PROCESS) AND THE HOOK EFFECT IS EXHIBITED BETWEEN 36 AND 64 MG/DL, AND THE REPORTED RECOVERY DROPS OFF TO APPROX 3-7MG/DL. NO AFFECT TO PT TREATMENT OR LAB PERSONNEL WAS REPORTED AS THIS EVENT WAS DISCOVERED IN HOUSE AND NO PT RESULTS WERE REPORTED FROM THIS LAB.