FDA Device recall Z-2869-2018
BD BBL GC-Lect Agar
- FDA Device
- Class II
- terminated
- Published 2018-08-29
On 2018-08-29 the FDA classified a Class II recall of BD BBL GC-Lect Agar by Becton Dickinson And, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2869-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2018-08-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Becton Dickinson And |
| Distribution | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, ID, IN, KS, KY, MA, MI, MS, MT, NC, NY, OK, OR, PA, SC, TN, TX, WA, WI |
Product
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
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.
Identifiers
| code_info | 8110781 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2869-2018%22
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