The Recall Desk
HighFDA (Devices)·Z-2628-2014·Announced 2014-09-24

Becton Dickinson Recalls Vancomycin Screen Agar Due to False Resistance Results

Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the product may allow susceptible bacteria to grow, leading to false resistance 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 is classified as FDA Class II and involves a risk of harm (delayed identification of bacterial resistance) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Becton Dickinson & Co. is recalling 28,540 units of BD BBL Vancomycin Screen Agar, Catalog number 222204. The affected lots are 4080291, 4042217, 4048040, 4052349, 4058242, 4073274, and 4127728. The product was distributed nationwide in the United States and internationally to Belgium, Canada, Colombia, India, Mexico, Singapore, and Taiwan.

The recall was initiated because the agar may have exhibited breakthrough growth of vancomycin-susceptible Enterococcus species control organisms. This defect can cause the agar to appear as if the bacteria are resistant to vancomycin when they are actually susceptible. If a laboratory does not perform quality control, this error could lead to a delay in identifying the true susceptibility of the bacteria, potentially affecting subsequent antimicrobial susceptibility testing workup.

This recall is classified as Class II by the FDA. The product is used in clinical laboratories to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. Users should stop using the affected lots and contact Becton Dickinson for further instructions.

The recalled product

Product
BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Affected units
28,540

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)

  • Lot numbers - 4080291 4042217 4048040 4052349 4058242 4073274 4127728

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically: