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U.S. Department of Health and Human Services

Class 3 Device Recall Palcam Agar Base, Acumedia

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  Class 3 Device Recall Palcam Agar Base, Acumedia see related information
Date Initiated by Firm August 02, 2018
Create Date October 26, 2018
Recall Status1 Terminated 3 on December 18, 2020
Recall Number Z-0283-2019
Recall Event ID 81115
Product Classification Culture media, selective and differential - Product Code JSI
Product Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Code Information Lot 110321B
Recalling Firm/
Acumedia Manufacturers, Inc.
740 E Shiawassee St
Lansing MI 48912-1218
For Additional Information Contact John Guenther
800-234-5333 Ext. 2362
Manufacturer Reason
for Recall
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
FDA Determined
Cause 2
Error in labeling
Action Product Notification letters dated 8/2/18 were sent to customers.
Quantity in Commerce 22 bottles
Distribution Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
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.