The Recall Desk
ModerateFDA (Devices)·Z-1799-2013·Announced 2013-07-31

Becton Dickinson Recalls Schaedler K-V Agar Plates Due to Reduced Vancomycin

Becton Dickinson is recalling specific lots of Schaedler K-V Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves reduced efficacy of a diagnostic medium rather than a direct physical injury or acute health threat to the user.

Plain-English summary

Becton Dickinson & Co. is recalling 92 cartons of BD BBL Schaedler K-V Agar with 5% Sheep Blood, catalog # 221555. The affected product is identified by Lot 3078263 and an expiration date of 5/16/13. The recall was initiated because the microbiological identification media may exhibit reduced levels of Vancomycin.

The product is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial. The recall is classified as Class II by the FDA. The affected units were distributed worldwide, including the United States, Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.

Users of the product should stop using the affected lot and contact Becton Dickinson for further instructions or a replacement.

The recalled product

Product
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancom
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
92

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 3078263 Exp 5/16/13

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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