Z-0283-2019 Class III Terminated
FDA device recall Z-0283-2019 was initiated by Acumedia Manufacturers, Inc. on August 2, 2018 and is designated Class III. 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. The recall status is terminated (terminated December 18, 2020). Affected quantity: 22 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- August 2, 2018
- Termination Date
- December 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 bottles
Product 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 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.
Distribution Pattern
Worldwide distribution and US nationwide in the states of CA, GA, MN, OR, RI, TX, and WY. Countries of Canada, Mexico, Scotland, and Uruguay.
Code Information
Lot 110321B