FDA Recall
Terminated
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.
Recall: Z-0283-2019
·
Initiated August 2, 2018
Recall
- Recall Number
- Z-0283-2019
- Event Number
- 81115
- Firm
- Acumedia Manufacturers, Inc.
- FEI Number
- 1120041
- Product Code
- JSI
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- August 2, 2018
- Terminated
- December 18, 2020
- Address
- 740 E Shiawassee St, Lansing, MI, 48912-1218
Description
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.
Reason
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.
Action
Product Notification letters dated 8/2/18 were sent to customers.
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.
Quantity
22 bottles