BIOPLEX 2200 ANTI-CCP REAGENT PACK

Description of Event or Problem

BIO-RAD LABORATORIES HAS RECEIVED REPORTS OF DISCREPANT RESULTS WITH LOT NO. 301481 FROM FOUR CUSTOMERS PERFORMING LOT-TO-LOT VALIDATION AGAINST PREVIOUS LOTS. INTERNAL TESTING AT BIO-RAD HAS DEMONSTRATED THAT LOT NO. 301481 EXHIBITS A REDUCTION IN SPECIFICITY (POTENTIAL FOR FALSE POSITIVE RESULTS). THERE WERE NO REPORTED ADVERSE EVENT WITH THIS LOT. HOWEVER,FALSE POSITIVE ANTI-CCP RESULTS COULD LEAD TO INCORRECT DIAGNOSIS OF RHEUMATOID ARTHRITIS AND UNNECESSARY MEDICAL TREATMENT.

Additional Manufacturer Narrative

BIO-RAD LABORATORIES HAS RECEIVED REPORTS OF DISCREPANT RESULTS WITH LOT NO. 301481 FROM FOUR CUSTOMERS PERFORMING LOT-TO-LOT VALIDATION AGAINST PREVIOUS LOTS. INTERNAL TESTING AT BIO-RAD HAS DEMONSTRATED THAT LOT NO. 301481 EXHIBITS A REDUCTION IN SPECIFICITY. THE BIAS WAS OBSERVED ON THE LOW END OF THE ASSAY RANGE AND NONE OF THE FALSE POSITIVE RESULTS OBSERVED EXCEEDED 9 U/ML (3X CUT-OFF). THIS REDUCTION IN SPECIFICITY MAY LEAD TO AN INCREASE IN THE NUMBER OF FALSE POSITIVES AND COULD LEAD TO INCORRECT DIAGNOSIS OF RHEUMATOID ARTHRITIS AND UNNECESSARY MEDICAL TREATMENT.