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Class 3 Device Recall Palcam Agar Base, Acumedia |
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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
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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
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For Additional Information Contact |
John Guenther 800-234-5333 Ext. 2362
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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.
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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
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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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