The Recall Desk
HighFDA (Devices)·Z-2869-2018·Announced 2018-08-29

BD BBL GC-Lect Agar Recalled Due to Incorrect Antibiotic Ingredient

Becton Dickinson is recalling BD BBL GC-Lect Agar plates because some were made with Gentamicin instead of Vancomycin, which may cause false negative gonorrhea test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the defect (incorrect antibiotic) leads to false negative diagnostic results, potentially causing incorrect or delayed treatment, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Becton Dickinson & Co. is recalling 10,360 plates of BD BBL GC-Lect Agar (Cat. No. 297715, Code 8110781). This product is a selective medium used to enhance the growth and recovery of Neisseria gonorrhoeae while inhibiting contamination bacteria and fungi.

A portion of this lot was manufactured using Gentamicin instead of Vancomycin. Gentamicin is an inhibitory agent for Neisseria organisms. Because the product is designed to promote the growth of these specific bacteria, the presence of Gentamicin may inhibit their growth. This can lead to false negative results or delayed results, potentially resulting in incorrect or delayed treatment for patients.

The affected products were distributed in the United States in the 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. Users should check their inventory for the specific lot code and discontinue use of the affected plates.

The recalled product

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.
Affected units
10,360

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 8110781

Distribution