BD Max Enteric Viral Panel EU Extraction Tube Sealing Defect
Becton Dickinson is recalling BD Max Enteric Viral Panel EU kits because foil bags containing extraction tubes may not have been sealed properly.
What this means for you
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 potential risks without confirmed harm.
Plain-English summary
Becton Dickinson & Co. is recalling 469 units of the BD Max Enteric Viral Panel EU (Catalog # 443985). The recall affects specific lots with expiration dates of November 1, 2020, and November 7, 2020.
The recall was initiated because the foil bags containing the extraction tubes for the BD MAX Reagent products may not have been sealed properly. This defect could potentially compromise the integrity of the extraction tubes.
The affected products were distributed to 38 U.S. states and Puerto Rico, as well as to 12 countries worldwide, including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan. Users of these products should stop using the affected kits and contact Becton Dickinson for further instructions.
The recalled product
- Product
- Kit BD Max Enteric Viral Panel EU Catalog # 443985
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 469
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 # 9085674
- UDI (GTIN
- DI+PI): (01)00382904439859 (17)201101(10)9085674(30)1
- Exp: 11/1/2020 Lot # 9107980
- DI+PI): (01)00382904439859 (17)201107(10)9107980(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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