Z-2869-2018 Class II Terminated
FDA device recall Z-2869-2018 was initiated by Becton Dickinson & Co. on Jun 21, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 9, 2019). Affected quantity: 10,360 plates.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2018
- Initiation Date
- Jun 21, 2018
- Termination Date
- Jul 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2869-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026