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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Becton Dickinson & Co.
- 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.
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