THE PATIENT'S ATTORNEY CLAIMS THAT THE PT (B)(6) WAS TESTED AND FOUND TO BE POSITIVE FOR (B)(6) BASED ON THE USE OF A CELLESTIS QUANTIFERON (B)(6) GOLD TEST. THE ASSUMPTION OF THE TEST WAS PERFORMED ON A LOT OF (B)(6) TUBES WHICH WERE RECALLED BY THE FIRM ((B)(4)). (B)(6) WAS PUT ON AGGRESSIVE TREATMENT. (B)(6) COULD NOT TAKE HER RHEUMATOID ARTHRITIS (RA) MEDICATION WHILE SHE WAS BEING TREATED. AFTER RECEIVING NOTIFICATION OF THE RECALL, (B)(6) WAS RE-TESTED BY 2 DIFFERENT LABORATORIES AND FOUND TO BE NEGATIVE. THE PATIENT'S ATTORNEY CLAIMS THAT (B)(6) SUFFERED THE RECURRENCE OF SERIOUS RA SYMPTOMS AND MISSED WORK.
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Patient 1
AS A RESULT OF A CAPA INVESTIGATION, PAST LEGAL COMMUNICATION WAS FOUND THAT WAS IDENTIFIED AS REQUIRING A MEDWATCH REPORT. THE COMPANY HAS DECIDED TO SUBMIT THIS MDR FOR INFORMATION PURPOSES IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803. BASED UPON THE INTENDED USE OF THE PRODUCT, IF A POSITIVE RESULT IS OBTAINED, THE PHYSICIAN IS ADVISED TO REPEAT THE TEST FOR CONFIRMATION, AND IN GENERAL THE RESULTS OF THE SCREENING TEST ARE TO BE TAKEN INTO CONSIDERATION WITH THE PATIENT'S EPIDEMIOLOGICAL HISTORY, CURRENT MEDICAL STATUS AND RESULTS OF OTHER DIAGNOSTIC EVALUATIONS. THE ALLEGED PROBLEMS REPORTED ARE THE OUTCOME OF DIAGNOSIS, AND SUBSEQUENT TREATMENT. CELLESTIS FILED NOTIFICATION OF THEIR VOLUNTARY RECALL THROUGH THE REGIONAL FDA DISTRICT RECALL OFFICE ON 10/16/2012. CLOSURE OF THE RECALL BY THE FDA WAS RECEIVED 4/25/2013