Class 3 Device Recall Palcam Agar Base, Acumedia

• Date Initiated by Firm: August 02, 2018
• Create Date: October 26, 2018
• Recall Status: Terminated 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/ Manufacturer: 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: 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.