Z-1093-2017 Class II Terminated
FDA device recall Z-1093-2017 was initiated by Acumedia Manufacturers, Inc. on April 22, 2016 and is designated Class II. Reason for recall: light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter ma… The recall status is terminated (terminated September 19, 2018). Affected quantity: 482.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- April 22, 2016
- Termination Date
- September 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 482
Product Description
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Reason for Recall
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Distribution Pattern
Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
Code Information
7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B