Becton Dickinson Recalls BBE Anaerobe Agar Due to Reduced Vancomycin
Becton Dickinson is recalling BBE Anaerobe Laked Sheep Blood Agar plates because they may contain reduced levels of Vancomycin.
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. The hazard involves reduced levels of an antibiotic in a laboratory medium, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 42 cartons of BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, Catalog # 297260. The affected product is packaged in cartons of 100 plates and is identified by Lot 3071112 with an expiration date of 5/28/13.
The recall was initiated because the microbiological identification media may exhibit reduced levels of Vancomycin. This product is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
The affected units were distributed worldwide, including the United States (nationwide), Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is…
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 42
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 3071112 Exp 5/28/13
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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