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Recall Observatory FDA recall evidence

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

August 02, 2018

Class III

Product summary

Firm
Acumedia Manufacturers, Inc.
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

    reason.labeling_packaging · v1.0.0

    label is incorrect