BD BBL¿ ACRIDINE ORANGE STAIN

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO BOTTLE ACRIDINE ORANGE STAIN 250ML 4 EA, CATALOG NUMBER 212537, AND COMPLAINT #(B)(6) FOR ISSUES DIFFERENTIATING BACTERIA. COMPONENTS ARE MILLED AND BLENDED (WHERE REQUIRED) AND DISPENSED INTO CONTAINERS. FOLLOWING QC RELEASE, AND BASED UPON INVENTORY DEMAND, FINAL PACKAGING OPERATIONS OCCUR, WHICH INCLUDE DISPENSING INTO AND LABELING OF FINAL CONFIGURATIONS, FOLLOWED BY TRANSPORT TO THE DISTRIBUTION CENTER. COMPLAINT INVESTIGATION TYPICALLY INVOLVES A REVIEW OF THE COMPLAINT BATCH HISTORY RECORD. NO COMPLAINT LOT OF MATERIAL 212537 WAS PROVIDED, THEREFORE NO BATCH HISTORY REVIEW COULD BE PERFORMED. RELEASE TESTING FOR THIS PRODUCT INCLUDES SOLUTION APPEARANCE, AND CULTURAL RESPONSE WITH ORGANISMS AS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS. ALL QC RESULTS MUST MEET THE COA SPECIFICATIONS PRIOR TO RELEASE. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO COMPLAINTS ON THIS PRODUCT FOR ANY REASON. NO PHOTOS OR RETURNS WERE RECEIVED. THIS COMPLAINT IS NOT CONFIRMED. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED WHEN USING BD BBL¿ ACRIDINE ORANGE STAIN HAS PERFORMANCE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDE THE INTIAL REPORTER: RAPID TEST FOR PRESENCE OF MICROORGANISMS (BACTERIA, YEAST, MOLD) LIMITATIONS OF METHOD MULTIPLE STUDIES MENTIONED ACRIDINE ORANGE¿S INABILITY TO DISCRIMINATE BETWEEN A LIVE AND DEAD CELL. SAW POOR CORRELATION BETWEEN THIS METHOD AND INGREDIENTS WHERE THERE WAS A HIGH LEVEL OF NON-VIABLE BACTERIA DUE TO A PROCESS STEP (E.G. BLANCHING OF VEGETABLES).

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHEN USING BD BBL¿ ACRIDINE ORANGE STAIN HAS PERFORMANCE ISSUES THE FOLLOWING INFORMATION WAS PROVIDE THE INITIAL REPORTER: RAPID TEST FOR PRESENCE OF MICROORGANISMS (BACTERIA, YEAST, MOLD) LIMITATIONS OF METHOD MULTIPLE STUDIES MENTIONED ACRIDINE ORANGE¿S INABILITY TO DISCRIMINATE BETWEEN A LIVE AND DEAD CELL. SAW POOR CORRELATION BETWEEN THIS METHOD AND INGREDIENTS WHERE THERE WAS A HIGH LEVEL OF NON-VIABLE BACTERIA DUE TO A PROCESS STEP (E.G. BLANCHING OF VEGETABLES).