Recall Z-2869-2018— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2018-06-21, terminated 2019-07-09. It names one FDA 510(k) clearance: K864803. 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-21
- Terminated
- 2019-07-09
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.