BD Max ExK DNA 2 USA Extraction Tube Sealing Defect Recall
Becton Dickinson is recalling BD Max ExK DNA 2 USA kits because foil bags containing extraction tubes may not have been sealed properly.
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. The source text describes a potential sealing defect but does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling the BD Max ExK DNA 2 USA kit (Catalog # 442819). The recall is due to a manufacturing defect where the foil bags containing the extraction tubes may not have been sealed properly.
The affected product is identified by Lot #9114654 and has an expiration date of 11/7/2020. The distribution pattern includes numerous U.S. states and territories, as well as several international locations including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan.
Consumers and healthcare facilities should stop using the affected kits and contact Becton Dickinson for further instructions or a replacement.
The recalled product
- Product
- Kit BD Max ExK DNA 2 USA; Catalog # 442819
- Manufacturer
- Becton Dickinson & Co.
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 (4)
- Lot #9114654
- UDI (GTIN
- DI+PI):(01)00382904428198 (17)201107(10)9114654(30)1
- Exp: 11/7/2020
Distribution
Part of a larger recall action
This product is one of 19 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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