Recall Z-0196-2018 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Becton Dickinson & Co.
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.
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | Listeria monocytogenes contamination of non-sterile plated media |
| Root cause | Material/Component Contamination |
| Action | BD Life Sciences initiated communication with distributors by issuing Urgent Product Recall and Customer Response Form notices via UPS mailing on May 22, 2017. General customers were issued Urgent Product Recall and Customer Response Form letters via UPS mailing on May 25, 2017. - General customers were advised to visually inspect all non-sterile prepared media prior to use to assure that there is no surface and/or subsurface contamination. If the customer observes a plate without evidence of microbial contamination that grows Listeria, please consult the clinician to make sure this result |
| Quantity | 250, 300 plates |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.