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Recall Observatory FDA recall evidence

Device 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.

Z-0196-2018

May 22, 2017

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 77609
Status
Terminated
Classification
Class II
Quantity
250, 300 plates
Official record key
device-enforcement:Z-0196-2018

Official wording

Reason: Listeria monocytogenes contamination of non-sterile plated media

Code information: Lot Number: 7032978 - Exp Date May 24, 2017 7048902 - Exp Date June 9, 2017

Distribution pattern: Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FA, HI, IA, IS, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT & WA; International - Canada, Guam and Japan

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Listeria monocytogenes contamination