The Recall Desk
HighFDA (Devices)·Z-0974-2015·Announced 2015-01-21

Becton Dickinson Recalls Trypticase Soy Agar and MacConkey II Agar Plates

Becton Dickinson is recalling specific lots of Trypticase Soy Agar and MacConkey II Agar plates due to low-level Listeria monocytogenes contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves Listeria monocytogenes, a high-risk pathogen, which corresponds to a High severity score under the rubric for high-risk pathogens without reported illness.

Plain-English summary

Becton Dickinson & Co. is recalling 7,617 cases of Trypticase Soy Agar with 5% Sheep Blood (TSA II) and MacConkey II Agar plates. The recall involves specific catalogue numbers and lot numbers identified in the agency's structured data. These products are non-sterile prepared plated media used for the growth of fastidious organisms and the detection of coliform organisms and enteric pathogens.

The recall is due to a low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of the affected media. The contamination is typically visible immediately upon removal from the packaging and is observed as 1-3 CFUs per plate when present.

The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico), Belgium, Canada, the Philippines, Singapore, and Taiwan. Users of these laboratory media should stop using the affected lots and contact Becton Dickinson for further instructions.

The recalled product

Product
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the d
Hazard

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)

  • Catalogue # 221291 with Lot #4050354
  • 4086399
  • 4099206 and 4143653
  • Catalogue #221261 with Lot # 4022158 4086443 4092199

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →