BD MULTITEST¿

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE (NON-SPECIFIC STAINING CREATING UNUSUAL STAINING PATTERNS FOR CD4+CD+8 POPULATIONS) WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DATA PROVIDED BY CUSTOMER WAS REVIEWED. RETAIN TESTING RESULTS SHOWED THE PRESENCE OF A NON-SPECIFIC STAINING. POTENTIAL CAUSE IS DETERMINED TO BE MANUFACTURING RELATED. ADDITIONAL CONTROLS HAVE BEEN PUT IN PLACE IN THE MANUFACTURING STAGE SPECIFIC TO THE SUPPLIED COMPONENT. CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE ROOT CAUSE AND PREVENTIVE ACTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH BD MULTITEST IVD REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC, CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761.

Additional Manufacturer Narrative

G.5. PMA / 510(K)#: K090967. G.5. PMA / 510(K)#: K170974. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH BD MULTITEST IVD REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FOUND THAT AS LONG AS THIS BATCH OF LOT IS STAINED, IN THE CD45 VS SSC, CD4 VS CD8 PLOTS, THERE ARE HUGE NOISE, BUT OTHER LOTS ARE NORMAL WITHOUT ANY NOISE. VERY CLEAN CD45 STAIN UNLIKE LOT 69761