The Recall Desk
ModerateFDA (Devices)·Z-2334-2019·Announced 2019-08-28

BD Max MRSA XT Extraction Tube Sealing Defect Recall

Becton Dickinson is recalling BD Max MRSA XT 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 61 units of the BD Max MRSA XT kit (Catalog # 443461). The recall involves specific lots with expiration dates in August and September 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 affect the integrity of the reagents.

The affected products were distributed to various states in the United States and to several countries worldwide, including Australia, Canada, and Japan. Users of these kits should stop using the affected lots and contact Becton Dickinson for further instructions.

The recalled product

Product
Kit BD Max MRSA XT; Catalog # 443461
Affected units
61

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 # 9106890
  • UDI (GTIN
  • DI+PI) :(01)00382904434618 (17)200828(10)9106890(30)1
  • Exp :8/28/2020 Lot # 9106891
  • DI+PI) :(01)00382904434618 (17)200909(10)9106891(30)1
  • Exp :9/9/2020 Lot # 9114657
  • DI+PI) :(01)00382904434618 (17)200922(10)9114657(30)1
  • Exp : 9/22/2020

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 →