BD MAX DNA MMK Lab Use Recalled for Incorrect Package Insert Volume
Becton Dickinson is recalling BD MAX DNA MMK Lab Use because the package insert incorrectly lists the diluent volume, which could affect assay results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which is defined as unlikely to cause adverse health consequences. The hazard is a labeling error that could affect assay results, fitting the criteria for a moderate severity score.
Plain-English summary
Becton Dickinson & Co. is recalling BD MAX DNA MMK Lab Use, catalog no. 442828. The recall is due to an error in the package insert, which incorrectly lists the volume of the primer and probe diluent required for the reconstitution of the master mix tube.
The product was distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution included Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand. The recall covers all units since 08/20/2014.
Adding the incorrect amount of diluent could have an effect on the assay. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- BD MAX DNA MMK Lab Use, catalog no. 442828
- Manufacturer
- Becton Dickinson & Co.
- Hazard
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)
- All since 08/20/2014
Distribution
Part of a larger recall action
This product is one of 2 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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