Recall Z-2585-2024 ยท KZB Automated Colony Counter
Becton Dickinson & Co.
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;
| Date | Aug 14, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | There is a potential risk that the image colony count does not adequately reflect the actual plate colony count and may lead to inaccurate counts that would impact patient diagnosis and subsequent care. |
| Root cause | Under Investigation by firm |
| Action | On July 9, 2024, "URGENT: Medical Device Product Correction" letters were sent to customers. Actions for Clinical Users: Users must review the plate images against the actual agar plate to verify the automated colony count results. Actions to be taken by customer: 1. Ensure the contents of this notification are read and understood. 2. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact not |
| Quantity | 23 units |
| Distribution | US distribution to states of: CO, CT, IA, IL, KY, MD, MI, MN, NC, NJ, NY, OH, OK, SC, TN, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.