The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0196-2018·Announced 2017-12-13

Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Listeria Contamination

Becton Dickinson is recalling Trypticase Soy Agar with 5% Sheep Blood plates because they are contaminated with Listeria monocytogenes. The affected lots are distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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, and is classified as FDA Class II. Per the rubric, high-risk pathogens without reported illness or hospitalization warrant a score of 3.

Plain-English summary

Becton Dickinson & Co. is recalling TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261, due to contamination with Listeria monocytogenes. This product is a non-sterile plated medium used for cultivating fastidious microorganisms and visualizing hemolytic reactions produced by bacterial species.

The recall involves 250 and 300-plate quantities. The affected lot numbers are 7032978 (expiration date May 24, 2017) and 7048902 (expiration date June 9, 2017). The products were distributed worldwide, including the United States, Canada, Guam, and Japan.

Users should stop using the affected products and contact Becton Dickinson for further instructions. This recall is classified as Class II by the FDA.

The recalled product

Product
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species.
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 (3)

  • Lot Number: 7032978 - Exp Date May 24
  • 2017 7048902 - Exp Date June 9
  • 2017

Distribution

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