Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: 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 detection of coliform organisms and enteric pathogens.
This recall has been terminated (originally issued April 22, 2016).
- Recall Initiated
- March 28, 2016
- Posted
- April 22, 2016
- Terminated
- November 14, 2016
- Recall Number
- Z-1559-2016
- Quantity
- 88,300 plates (883 cartons)
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
Distribution
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TX, UT, VA, WA.
Lot / Code Info
Cat. Number Lot Number 221291 6034889
Root Cause
Material/Component Contamination
Action Taken
BD sent an Urgent Product Recall letter dated March 2016 to all US customers via UPS or email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected lots and discard any remaining product. BD will replace the discard inventory. Customers were asked to complete and fax the attached form to : Attention Regulatory Compliance, Fax: 410-316-4258 or email to BDRC2@bd.com.