The Recall Desk
ModerateFDA (Devices)·Z-2337-2019·Announced 2019-08-28

Becton Dickinson Recalls BD Max Enteric Viral Panel Reagent Kits

Becton Dickinson is recalling 27 units of BD Max Enteric Viral Panel RUO 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 packaging defect (improper sealing) without reporting any specific injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling 27 units of the BD Max Enteric Viral Panel RUO, Catalog # 443715. The recall was initiated because the foil bags containing extraction tubes for these reagent products may not have been sealed properly.

The affected units are identified by Lot # 9114647 and have an expiration date of 11/7/2020. The products were distributed to various locations in the United States, including Alabama, Arizona, California, and New York, as well as internationally to countries such as Australia, Brazil, Canada, and Japan.

Consumers and healthcare facilities should stop using the affected kits and contact Becton Dickinson for further instructions or a replacement.

The recalled product

Product
Kit BD Max Enteric Viral Panel RUO; Catalog # 443715
Affected units
27

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 # 9114647
  • UDI (GTIN
  • DI+PI): (01)00382904437152 (17)201107(10)9114647(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 →