Becton Dickinson & Co. recalls BD BBL GC-Lect Agar; Cat. No. 297715 The device is a selective medium providing enhanced growth and recovery of Neisser…

Recall date

June 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2869-2018

FDA classification

Class II

Brand / firm

Becton Dickinson & Co.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.