BD MAX DNA MMK Recalled for Incorrect Package Insert Volume Instructions
Becton Dickinson is recalling BD MAX DNA MMK (SPC) because the package insert lists the wrong volume of diluent, 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a documentation error (incorrect volume in the package insert) that could affect assay results, fitting the criteria for a Low severity score.
Plain-English summary
Becton Dickinson & Co. is recalling 13,898 units of BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829. 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) and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand. The affected units are all those manufactured since 08/20/2014.
Adding the incorrect amount of diluent could have an effect on the assay. Users should stop using the product and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 13,898
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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