BD MAX Reagent Extraction Tubes Recalled for Improper Sealing
Becton Dickinson is recalling BD MAX Reagent extraction tubes because foil bags may not be sealed properly, potentially compromising product integrity.
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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a potential integrity issue (improper sealing) rather than a direct physical or biological threat, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 10 units of Kit BD Max ExK DNA 2 EU LUO (Catalog # 442820, Lot # 9114655). The recall is due to a manufacturing defect where the foil bags containing the extraction tubes may not have been sealed properly.
The affected products were distributed to 38 U.S. states, Puerto Rico, and 12 international countries including Australia, Canada, and China. The expiration date for the recalled units is November 7, 2020.
Consumers and healthcare facilities should stop using the affected extraction tubes and contact Becton Dickinson for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 10
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 # 9114655
- UDI (GTIN
- DI+PI): (01)00382904428204 (17)201107(10)9114655(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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