BD BBL¿ TB FLUORESCENT STAIN KIT M CONTAINS

Additional Manufacturer Narrative

H3. 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 WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO KIT TB FLUORESCENT STAIN KIT M, CATALOG NUMBER 212519, BATCH NUMBER 5224448, COMPLAINT # (B)(4) FOR CONTAMINATION. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING THE PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD FOR TB STAIN KIT M. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL THE RELEASE TESTING WAS SATISFACTORY. SATISFACTORY APPEARANCE FOR AURAMINE M COMPONENT IS ¿YELLOW SUSPENSION¿. BY DEFINITION A SUSPENSION IS ¿A MIXTURE IN WHICH PARTICLES ARE DISPERSED THROUGHOUT THE BULK OF THE FLUID¿. IT IS ALSO DEFINED AS ¿A MIXTURE IN WHICH ALL PARTICLES OF A SUBSTANCE ARE DISPERSED THROUGHOUT A GAS OR LIQUID. IF A SUSPENSION IS LEFT UNDISTURBED, THE PARTICLES ARE LIKELY TO SETTLE TO THE BOTTOM. THE PARTICLES IN A SUSPENSION ARE LARGER THAN THOSE IN EITHER A COLLOID OR A SOLUTION¿. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME THERE HAVE BEEN NO CONFIRMED COMPLAINTS FOR THE DEFECT IN QUESTION FOR THIS PRODUCT. FOUR PHOTOS RECEIVED IN A LIEU OF RETURN. THE FIRST PHOTO DEPICTS THE FRONT OF THE BOX WITH LABEL FOR TB FLUORESCENT STAIN KIT M 212519, BATCH NUMBER 5224448 AND EXPIRATION DATE 2026-06-30. THE SECOND PHOTO DEPICTS THE HAND HOLDING THE BOTTLE WITH YELLOW SUSPENSION AND PART OF THE LABEL SHOWS THE EXPIRATION DATE 20206-06-30, BATCH NUMBER NOT VISIBLE. THIRD PHOTO DEPICTS THE MICROSCOPIC VIEW WITH BRIGHT YELLOW GREEN BACKGROUND AND VERY SMALL BRIGHT DOTS. THE LAST PHOTO DEPICTS THE MICROSCOPIC VIEW OF FLUORESCENT BRIGHT YELLOW PRECIPITATES. THE RETENTION SAMPLE FROM THE COMPLAINT BATCH NUMBER 5224448 OF TB STAIN KIT M PART NUMBER 212519, WAS EVALUATED ALONG WITH A CONTROL BATCH FOR SOLUTION APPEARANCE OF THE AURAMINE M COMPONENT PART NUMBER 212514, BATCH NUMBER 5189943 AND EXPIRATION DATE 2026-06-30. THE SOLUTION APPEARANCE OF THE RETENTION SAMPLE FOR AURAMINE M COMPONENT FROM THE KIT WAS COMPARABLE TO THE CONTROL AND WAS A YELLOW SUSPENSION. THE PRECIPITATE IN QUESTION IS INHERENT TO THE STAIN AND DOES NOT AFFECT THE PERFORMANCE OF THE STAIN. STAINING WAS COMPLETED PER INSTRUCTIONS IN THE PRODUCT INSERT. SLIDES OF POSITIVE (M. TUBERCULOSIS ATCC 25177) AND NEGATIVE (B. SUBTILIS ATCC 6533) CONTROLS WERE EVALUATED AND GAVE SATISFACTORY STAINING RESULTS WITH THE RETENTION AND CONTROL BATCHES. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT CANNOT BE CONFIRMED. WATERS WILL CONTINUE TO TREND DCM COMPLAINTS FOR CONTAMINATION.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD BBL¿ TB FLUORESCENT STAIN KIT M THE USER NOTED SEDIMENT WHILE PEFORMING MICROSCOPIC TESTING, STATING THE SEDIMENT MADE MICROSCOPIC EXAMINATION FOR ACID-FAST BACILLI (AFB) DIFFICULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.