Recall Z-2869-2018 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Becton Dickinson & Co.
BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisseria gonorrhoeae and better inhibition of contamination bacteria and fungi.
| Date | Jun 21, 2018 |
| Status | Terminated |
| Reason | A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent of Neisseria organisms. This product is a selective plated medium to provide enhanced growth and recovery of N gonorrhoeae. Inhibited growth may cause a false negative result or a delayed result leading to incorrect or delayed treatment. |
| Root cause | Under Investigation by firm |
| Action | The firm, BD Diagnostic System, sent an "URGENT MEDICAL DEVICE PRODUCT RECALL" letter dated June 21, 2018, to its customers via UPS, to the attention of Microbiology Manager/Supervisor. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: I. Complete the Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Discard any remaining inventory of lot 8110781 . BD will process replacement of any disc |
| Quantity | 10,360 plates |
| Distribution | US Distribution in states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, ID, IN, KS, KY, MA, MI, MS, MT, NC, JH, NY, OK, OR, PA, SC, TN, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864803 | GC-LECT(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic, Feb 3, 1987 |