Recall StatusTerminated
Date Initiated2016-04-22
Date Terminated2018-09-19
Product Quantity482
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.
Firm 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
[email protected] 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.
Root Cause
Component design/selection
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.