The Recall Desk
ModerateFDA (Devices)·Z-2326-2019·Announced 2019-08-28

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.

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, 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
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.

See all 19 products in this recall →