The Recall Desk
ModerateFDA (Devices)·Z-2331-2019·Announced 2019-08-28

BD MAX Reagent Extraction Tube Foil Bags Recall

Becton Dickinson is recalling BD MAX Reagent extraction tube kits because foil bags 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 injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling 913 units of BD MAX CT/GC/TV Reagent kits (Catalog # 442970). The recall involves specific lots with expiration dates of April 14, 2020, and May 12, 2020.

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 reagents.

The affected products were distributed to 37 U.S. states, Puerto Rico, and 12 international countries. Users of these kits should stop using the affected lots and contact Becton Dickinson for further instructions.

The recalled product

Product
Kit BD Max CT/GC/TV; Catalog # 442970
Affected units
913

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 (10)

  • Lot # 9080876
  • UDI (GTIN
  • DI+PI): (01)00382904429706 (17)200414(10)9080876(30)1
  • Exp: 4/14/2020 Lot #9092733
  • DI+PI): (01)00382904429706 (17)200414(10)9092733(30)1
  • Exp: 4/14/2020 Lot #9092734
  • DI+PI): (01)00382904429706 (17)200512(10)9092734(30)1
  • Exp: 5/12/2020 Lot #9106875
  • DI+PI): (01)00382904429706 (17)200512(10)9106875(30)1
  • Exp: 5/12/2020

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 →