BD Max ExK DNA 1 USA Extraction Tube Sealing Defect Recall
Becton Dickinson is recalling 115 units of BD Max ExK DNA 1 USA kits because foil bags containing extraction tubes may not be 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 illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 115 units of the BD Max ExK DNA 1 USA kit (Catalog # 442817). The recall involves specific lots: 9085666, 9106886, and 9127935.
The recall was initiated because the foil bags containing the extraction tubes for BD MAX Reagent products may not have been sealed properly. This defect could potentially compromise the integrity of the reagents.
The affected products were distributed to 38 U.S. states and Puerto Rico, as well as to 12 international locations including Australia, Belgium, Brazil, Canada, Chile, China, Hong Kong, Japan, Korea, Mexico, Singapore, and Taiwan. Users should check their inventory for the specific lot numbers listed and contact Becton Dickinson for further instructions.
The recalled product
- Product
- Kit BD Max ExK DNA 1 USA; Catalog # 442817
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 115
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 (8)
- Lot # 9085666
- UDI (GTIN
- DI+PI): (01)00382904428174 (17)201024(10)9085666(30)1
- Exp: 10/24/2020 Lot #9106886
- DI+PI): (01)00382904428174 (17)201107(10)9106886(30)11
- Exp: 11/7/2020 Lot #9127935
- DI+PI): (01)00382904428174 (17)201130(10)9127935(30)11
- Exp: 11/30/2020
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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