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U.S. Department of Health and Human Services

Class 2 Device Recall Neogen

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  Class 2 Device Recall Neogen see related information
Date Initiated by Firm April 22, 2016
Create Date January 25, 2017
Recall Status1 Terminated 3 on September 19, 2018
Recall Number Z-1093-2017
Recall Event ID 76053
Product Classification Culture media, non-selective and non-differential - Product Code JSG
Product Tryptic Soy Agar, Acumedia PN 7100
500g, 2Kg, 10Kg, and 50Kg sizes
Code Information 7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B
Recalling Firm/
Manufacturer		 Acumedia Manufacturers, Inc.
740 E Shiawassee St
Lansing MI 48912-1218
For Additional Information Contact
800-234-5333
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action Neogen sent a Recall Notification dated March 8, 2016, to all affected customers on April 22, 2016. via e-mail. The recall notification included a description of the reason for the recall, affected product, and offer for replacement. If any Tryptic Soy Agar from this lot remains in your inventory, and you would like to replace this lot, please contact the customer service team at Neogen Corporation by email at foodsafety@neogen.com or by telephone at (800)-234-5333. We would like to assure you that we are committed to providing products that meet our strict quality standards for your testing needs. Neogen will investigate this isolated incident to determine the root cause and implement measures to ensure that this issue does not happen in the future.
Quantity in Commerce 482
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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