BD BBL¿ GRAM CRYSTAL VIOLET

Description of Event or Problem

IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ GRAM CRYSTAL VIOLET, THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. D9. RETURNED TO MANUFACTURER ON: 26-FEB-2026. H3. DEVICE EVAL BY MANUFACTURER?: YES. INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT RELATED TO BOTTLE GRAM CRYSTAL VIOLET 250ML, CATALOG NUMBER 212525, BATCH NUMBER 5112529, COMPLAINT # (B)(4) FOR UNSATISFACTORY PERFORMANCE. COMPONENTS ARE MIXED AND DISPENSED INTO THE APPROPRIATE CONTAINERS. AFTER QC TESTING PRODUCT IS RELEASED AND TRANSPORTED TO THE DISTRIBUTION CENTER. THE COMPLAINT INVESTIGATION INCLUDED A BATCH HISTORY REVIEW OF GRAM CRYSTAL VIOLET. THE BATCH HISTORY RECORD REVIEW INDICATED NO DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY. 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. ONE PHOTO WAS RECEIVED. THE PHOTO DEPICTS A MICROSCOPIC VIEW OF GRAM-NEGATIVE CULTURE AND TWO DARK PURPLE NONBACTERIAL ARTIFACTS. RETURN WAS RECEIVED ON 02/26/26 AFTER TESTING WAS COMPLETED. PACKAGE WAS RECEIVED DAMAGED AND SPILLED WITH MIXED MATERIALS. CONTENT INSIDE NOW MIXED MATERIALS AND CAN BE CONTAMINATED. NO FURTHER TESTING CAN BE CONDUCTED THIS TIME A RETENTION SAMPLE FROM THE COMPLAINT BATCH WAS EVALUATED ALONG WITH A CONTROL BATCH OF CRYSTAL VIOLET. THE SOLUTION APPEARANCE OF RETENTION SAMPLE WAS SATISFACTORY AND COMPARABLE TO THE CONTROL; ALL WERE DEEP PURPLE SOLUTIONS WITH NO VISIBLE PRECIPITATE. SLIDES OF E. COLI ATCC 25922 AND S. AUREUS ATCC 25923 CONTROLS WERE EVALUATED AND HAD SATISFACTORY STAINING RESULTS FOR RETENTION AND CONTROL BATCHES. TEN FIELDS OF EACH SMEAR WERE EXAMINED IN DETAIL USING OIL IMMERSION LENS OF A LIGHT MICROSCOPE. NO EXCESSIVE PRECIPITATE, ARTIFACTS OR BACTERIAL CONTAMINATION WERE SEEN. THE RETENTION SAMPLE WAS COMPARABLE TO THE CONTROL. THIS COMPLAINT IS NOT CONFIRMED. BD WILL CONTINUE TO TREND DCM COMPLAINTS FOR UNSATISFACTORY PERFORMANCE.

Description of Event or Problem

IT WAS REPORTED AFTER USING ONE (1) BD BBL¿ GRAM CRYSTAL VIOLET, THERE WERE ARTIFACTS VISIBLE IN THE SLIDE, RENDERING THE STAIN UNUSABLE. USER REPORTS THE APPEARANCE OF THE ARTIFACTS APPEARED SIMILAR TO GRAM POSITIVE COCCI. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.