Recall Z-0283-2019 ยท JSI Culture Media, Selective And Differential
Acumedia Manufacturers, Inc.
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.
| Date | Aug 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | Product Notification letters dated 8/2/18 were sent to customers. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.