FDA Enforcement Class II Terminated

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.

Recall: Z-1559-2016 · Reported May 4, 2016

Enforcement

Recall Number
Z-1559-2016
Event ID
73783
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Co.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
May 4, 2016
Initiation Date
March 28, 2016
Classification Date
April 22, 2016
Termination Date
November 14, 2016
Address
7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States

Description

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.

Reason

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.

Code Info

Cat. Number Lot Number 221291 6034889

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.

Quantity

88,300 plates (883 cartons)