BD GeneOhm Cdiff Assay Recalled Due to Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay because of leakage in Cepheid SmartCycler reaction tubes.
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay, Catalog #441400 200, box tests 1-3. The recall is due to leakage in Cepheid SmartCycler reaction tubes. The affected lots are 08T11248 (expiration date 2012-06-22) and 08T11251 (expiration date 2012-06-26).
The BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test used for the direct detection of the C. difficile toxin gene (tcdB) in human liquid or soft stool specimens. It is intended to aid in the diagnosis of Clostridium difficile-associated disease (CDAD). The product was distributed nationwide, including in 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.
Healthcare facilities and laboratories should stop using the affected product and contact Becton Dickinson & Co. for instructions on return or replacement. The FDA has classified this recall as Class II, meaning it 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.
The recalled product
- Product
- BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 57
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 (2)
- Lot/ Exp. 08T11248 2012-06-22
- 08T11251 2012-06-26
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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