BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 38 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 involves leakage in reaction tubes without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 38 kits of the BD GeneOhm MRSA ACP Assay, Catalog #441637. The recall is due to leakage in the Cepheid SmartCycler reaction tubes. The affected lots are 03T11346Z with an expiration date of 2012-06-11 and 03T12034 with an expiration date of 2012-07-31.
The 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 nationwide distribution, 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.
Healthcare facilities and consumers should stop using the affected product and contact Becton Dickinson & Co. for instructions on return or replacement.
The recalled product
- Product
- BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 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
- 38
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 date: 03T11346Z 2012-06-11
- 03T12034 2012-07-31
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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