Z-2869-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- June 21, 2018
- Termination Date
- July 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,360 plates
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
8110781