Device 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.
Z-0283-2019
Product summary
- Event
- Event 81115
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22 bottles
- Official record key
device-enforcement:Z-0283-2019
Official wording
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 information: Lot 110321B
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.
Derived failure modes
-
Labeling or packaging
label is incorrect