BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 68 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.
What this means for you
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 a physical defect (leakage) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 68 kits of the BD GeneOhm MRSA ACP Assay, Catalog #441639. The recall is due to leakage in the Cepheid SmartCycler reaction tubes. The affected product is a qualitative in vitro diagnostic test used to detect methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in healthcare settings.
The recall covers Lot 03T11345ZU with an expiration date of 2012-07-09. 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 consumers should stop using the affected kits and contact Becton Dickinson & Co. for instructions on return or replacement.
The recalled product
- Product
- BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 68
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. 03T11345ZU 2012-07-09
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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