FDA Enforcement
Class III
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
·
Reported November 7, 2018
Enforcement
- Recall Number
- Z-0283-2019
- Event ID
- 81115
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Acumedia Manufacturers, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 7, 2018
- Initiation Date
- August 2, 2018
- Classification Date
- October 26, 2018
- Termination Date
- December 18, 2020
- Address
- 740 E Shiawassee St, N/A, Lansing, MI, 48912-1218, United States
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.
Code Info
Lot 110321B
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