BD FACS LYSING SOLUTION 10X 150 TESTS

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2916837-2021-00437 WAS SENT IN ERROR. THIS COMPLAINT IS NOT MDR REPORTABLE. PER CFR REGULATION 809.3. THIS DEVICE IS NOT CONSIDERED AN IVD USED FOR CLINICAL DIAGNOSIS AND IS THEREFORE EXEMPT FROM MDR REPORTING.

Description of Event or Problem

IT WAS REPORTED THAT THE BD FACS LYSING SOLUTION 10X 150 TESTS CONTAINED IFU FOR DIFFERENT REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSLYSING SOLUTION WAS RECEIVED BY APPLICATION SPECIALIST FOR TRAINING PURPOSES. THE CARTON BOX WITH THE REAGENT VIAL CONTAINED IFU FOR ANOTHER REAGENT. NO IMPACT IN THIS CASE AS THE REAGENT WILL BE USED BY BD EMPLOYEE FOR THE TRAINING AND DEMO PURPOSES. BUT IF A CUSTOMER RECEIVES A WRONG IFU WITH THE REAGENT, THERE MIGHT BE REPUTATION LOSS FOR BD, AND THE CUSTOMER WILL HAVE TO DO ADDITIONAL STEPS TO GET THE RIGHT IFU FOR THE REAGENT.

Additional Manufacturer Narrative

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 THAT THE BD FACS LYSING SOLUTION 10X 150 TESTS CONTAINED IFU FOR DIFFERENT REAGENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSLYSING SOLUTION WAS RECEIVED BY APPLICATION SPECIALIST FOR TRAINING PURPOSES. THE CARTON BOX WITH THE REAGENT VIAL CONTAINED IFU FOR ANOTHER REAGENT. NO IMPACT IN THIS CASE AS THE REAGENT WILL BE USED BY BD EMPLOYEE FOR THE TRAINING AND DEMO PURPOSES. BUT IF A CUSTOMER RECEIVES A WRONG IFU WITH THE REAGENT, THERE MIGHT BE REPUTATION LOSS FOR BD, AND THE CUSTOMER WILL HAVE TO DO ADDITIONAL STEPS TO GET THE RIGHT IFU FOR THE REAGENT.