Becton Dickinson Recalls BD MAX Reagent Extraction Tubes Due to Seal Defect
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, and the source text describes a potential sealing defect without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or precautionary measures where harm has not yet been reported.
Plain-English summary
Becton Dickinson & Co. is recalling 447 units of Kit BD Max ExK DNA 1 EU LUO (Catalog # 442818). The recall involves specific lots (9085668 and 9106887) distributed across numerous U.S. states and international locations, including Australia, Canada, and China.
The recall was initiated because the foil bags containing the extraction tubes may not have been sealed properly. This defect could potentially affect the integrity of the reagent products.
Users of these products should stop using the affected lots and contact Becton Dickinson for further instructions or replacement.
The recalled product
- Product
- Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 447
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 (6)
- Lot# 9085668
- UDI (GTIN
- DI+PI):(01)00382904428181 (17)201024(10)9085668(30)1
- Exp:10/24/2020 Lot # 9106887
- DI+PI):(01)00382904428181 (17)201107(10)9106887(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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