Z-1559-2016 Class II Terminated
FDA device recall Z-1559-2016 was initiated by Becton Dickinson & Co. on Mar 28, 2016 and is designated Class II. 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. The recall status is terminated (terminated Nov 14, 2016). Affected quantity: 88,300 plates (883 cartons).
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2016
- Initiation Date
- Mar 28, 2016
- Termination Date
- Nov 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88,300 plates (883 cartons)
Product 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 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 Pattern
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.
Code Information
Cat. Number Lot Number 221291 6034889
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1559-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026