BD GeneOhm VanR Assay Recalled Due to Reaction Tube Leakage
Becton Dickinson is recalling BD GeneOhm VanR Assay kits because reaction tubes may leak. The recall affects 5 kits distributed nationwide.
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 is leakage in reaction tubes, which is a functional defect without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Becton Dickinson & Co. is recalling the BD GeneOhm VanR Assay, Catalog # 441250. The recall is due to leakage in Cepheid SmartCycler reaction tubes. The product is a qualitative in vitro test used for the rapid detection of vancomycin-resistance genes directly from perianal or rectal swabs.
The recall involves 5 kits. The distribution pattern is nationwide, including California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, Wisconsin, and West Virginia. The specific lot number is 05T11042 with an expiration date of 2012-04-30.
Healthcare facilities and consumers should stop using the affected product. The source text does not specify further instructions for disposal or return, but users should contact the manufacturer or their supplier for guidance.
The recalled product
- Product
- BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 5
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/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
Distribution
Part of a larger recall action
This product is one of 5 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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