Becton Dickinson Recalls Vancomycin Screen Agar Due to Reduced Antimicrobial Levels
Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the media may contain reduced levels of vancomycin, potentially affecting test accuracy.
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 the hazard involves a risk of harm (inaccurate medical test results) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Co. is recalling 911 cartons of BD BBL Vancomycin Screen Agar (catalog # 222204). The recall involves Lot 3081136 (Expiration June 18, 2013) and Lot 3073114 (Expiration June 12, 2013). The product is a microbiological identification medium used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
The recall was initiated because the microbiological identification media may exhibit reduced levels of vancomycin. This defect could compromise the accuracy of the tests performed using these plates. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including the United States (nationwide), Belgium, Canada, Colombia, Mexico, Singapore, and Taiwan. Users of these products should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and returned to the manufacturer or disposed of according to local regulations, as the reduced vancomycin levels may render the test results unreliable.
The recalled product
- Product
- BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, 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 vancomycin and to pred
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 911
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 (3)
- Lot 3081136 Exp June 18
- 2013 Lot 3073114 Exp June 12
- 2013
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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